I will provide FDA product classification, device name, submission 510k, exempt list


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Description Product Code, Classify, Regulation Product Code Device Name Device Class (1, 2, 3) Regulation Number (CFR Title 21) Product Code, Classification, Panel Basic Plus Review Panel Medical Specialty Code, Class, Reg, GMP, 510K exempt Standard Plus GMP exempt 510K exempt Implant, Life Sustain Flag Malfunction reporting
Revisions 0 0 0
Delivery Time 2 Days 2 Days 2 Days
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About This Proposal

The Product Classification Files (excel format) contains (based on package you selected) Product code, device names, device class, regulation number (21 CFR), review panel, medical specialty, GMP exempt, submission type (510k, PMA, HDE, EAU), Implant, life sustain support, and malfunction reporting.

 The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892.

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The three classes and the requirements which apply to them are:

Device Class and Regulatory Controls

1. Class I General Controls

  • With Exemptions
  • Without Exemptions

2. Class II General Controls and Special Controls

  • With Exemptions
  • Without Exemptions

3. Class III General Controls and Premarket Approval

10 Reviews 5.0

  • PHSLLC

    Great job.
    Mar 22 2021

  • PHSLLC

    High quality work. Awesome job
    Jan 09 2021

  • PHSLLC

    Fast delivery. We will continue to work.
    Dec 11 2020
  • Seller's Feedback

    Great buyer. Decent Professional

  • PHSLLC

    Received the FDA review report accurately. Fast delivery
    Dec 09 2020
  • Seller's Feedback

    Nice buyer.

  • PHSLLC

    Fast delivery. We will continue to work.
    Dec 07 2020

  • prauDHI

    Great knowledge FDA regulations. Awesome.
    Dec 07 2020

  • PHSLLC

    Excellent communication. High skilled.
    Nov 05 2020

  • PHSLLC

    Accurate and details oriented. Great experience.
    Nov 02 2020
  • Seller's Feedback

    Great buyer. Very nice

  • PHSLLC

    Great seller. Awesome work.
    Oct 28 2020

  • PHSLLC

    Great service.
    Oct 23 2020
  • Seller's Feedback

    Great buyer.

  • PHSLLC

    Great job.
    Mar 22 2021

  • PHSLLC

    High quality work. Awesome job
    Jan 09 2021

  • PHSLLC

    Fast delivery. We will continue to work.
    Dec 11 2020
  • Seller's Feedback

    Great buyer. Decent Professional

  • PHSLLC

    Received the FDA review report accurately. Fast delivery
    Dec 09 2020
  • Seller's Feedback

    Nice buyer.

  • PHSLLC

    Fast delivery. We will continue to work.
    Dec 07 2020

  • prauDHI

    Great knowledge FDA regulations. Awesome.
    Dec 07 2020

  • PHSLLC

    Excellent communication. High skilled.
    Nov 05 2020

  • PHSLLC

    Accurate and details oriented. Great experience.
    Nov 02 2020
  • Seller's Feedback

    Great buyer. Very nice

  • PHSLLC

    Great seller. Awesome work.
    Oct 28 2020

  • PHSLLC

    Great service.
    Oct 23 2020
  • Seller's Feedback

    Great buyer.

  • There is currently no negative review for this proposal/service.

Basic $5.00 5

Product Code, Classify, Regulation Product Code Device Name Device Class (1, 2, 3) Regulation Number (CFR Title 21)

2 Days Delivery     0 Revisions
 Add to Cart Order Now ($5.00)

Standard $30.00 30

Product Code, Classification, Panel Basic Plus Review Panel Medical Specialty

2 Days Delivery     0 Revisions
 Add to Cart Order Now ($30.00)

Advance $60.00 60

Code, Class, Reg, GMP, 510K exempt Standard Plus GMP exempt 510K exempt Implant, Life Sustain Flag Malfunction reporting

2 Days Delivery     0 Revisions
 Add to Cart Order Now ($60.00)

  • Quantity:
    1
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    United States

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    English

    Positive Reviews

    Recent Delivery

    100%

    March 22, 2021


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