FDA 510(k), K110898, S.C.O.R.E.S. UNIT

FDA 510(k), K110898, S.C.O.R.E.S. UNIT

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510(K) Number: K110898
Device Name: S.C.O.R.E.S. UNIT
Manufacturer: DAVID C FURR
Device Classification Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Regulation Number: KCT
Classification Product Code: KXA
Date Received: 03/30/2011
Decision Date: 07/26/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
  • 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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