Premarket Notification(510k)

A 510k is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicateā€.

LMG can assist you to prepare your Traditional, Abbreviated or Special 510k submission to FDA.

Our FDA 510K Submission service includes:

  • Identification of device class, product code and regulation number
  • Identification of predicate device
  • Identification of 510k test requirements
  • Identification testing lab
  • Preparation of 510k documents
  • Submission of 510k document to FDA
  • Communicate to FDA on behalf of our client
  • Prepare clarifications to questions from FDA
  • Assistance in transfer of 510k review fees to FDA
  • Assistance in Establishment registration with FDA
  • Assistance in Device Listing with FDA

510k approval process flow diagram

FDA Registration - Latex and Nitrile gloves

Tests required for latex and nitrile gloves - FDA Submission

Biocompatibility tests required for examination and surgical gloves

Who is required to submit 510(K)?

 

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