510(k) Support

A 510(k) is the mechanism to clear your medical device for commercial distribution and allow the product to be marketed in the United States. Many Medical Device Companies need assistance with the structure, format and verification of the required elements to be included in their 510(k) prior to submission. Watermark’s 510(k) review and support service provides this assistance, including:

  • A review of your product user guide and label­ing (to be submitted with your 510(k))
  • Verification of the structure, format and re­quired elements of your 510(k)
  • Submission of your 510(k) to the U.S. FDA
  • Facilitation of the U.S. FDA government fee payment
  • Correspondence with the U.S. FDA on your behalf.

Watermark’s 510(k) review and support service can assist with your submission to prevent incomplete submissions and costly delays.

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