FDA 510(k), K162193, XenMatrix AB Surgical Graft
FDA 510(k), K162193, XenMatrix AB Surgical Graft
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510(K) Number: K162193
Device Name: XenMatrix AB Surgical Graft
Manufacturer: C.R. Bard
Device Classification Name: collagen surgical mesh containing drugs
Regulation Number: 878.3300
Classification Product Code: PIJ
Date Received: 08/04/2016
Decision Date: 12/23/2016
Regulation Medical Specialty: General & Plastic Surgery
Device Name: XenMatrix AB Surgical Graft
Manufacturer: C.R. Bard
Device Classification Name: collagen surgical mesh containing drugs
Regulation Number: 878.3300
Classification Product Code: PIJ
Date Received: 08/04/2016
Decision Date: 12/23/2016
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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