Collection: FDA 510(k)

FDA 510K documents available for fast-track requests typically delivered within 1 to 2 weeks. Publicly Available documents delivered within 24 business hours.

Use Search below to find the 510k you are looking for by:
  • Device Name
  • Manufacturer
  • Device Classification Name
  • Regulation Number
  • Classification Product Code
  • Date Received
  • Decision Date
  • Regulation Medical Specialty

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