FDA 510(k), K924953, FLUID COOLED BONE SAW BLADE, 6000 SERIES

FDA 510(k), K924953, FLUID COOLED BONE SAW BLADE, 6000 SERIES

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510(K) Number: K924953
Device Name: FLUID COOLED BONE SAW BLADE, 6000 SERIES
Manufacturer: JOHN KARPOWICZ
Device Classification Name: Blade, Saw, General & Plastic Surgery, Surgical
Regulation Number: GFA
Classification Product Code: KXA
Date Received: 09/30/1992
Decision Date: 01/21/1993
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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