FDA 510(k), K172593, XCelliStem Wound Powder
FDA 510(k), K172593, XCelliStem Wound Powder
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510(K) Number: K172593
Device Name: XCelliStem Wound Powder
Manufacturer: Clay Fette
Device Classification Name: Wound Dressing With Animal-Derived Material(S)
Regulation Number: KGN
Classification Product Code: 08/29/2017
Date Received: 03/16/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: XCelliStem Wound Powder
Manufacturer: Clay Fette
Device Classification Name: Wound Dressing With Animal-Derived Material(S)
Regulation Number: KGN
Classification Product Code: 08/29/2017
Date Received: 03/16/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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