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FDA 510(k), K163430, Prontosan Wound Gel
FDA 510(k), K163430, Prontosan Wound Gel
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510(K) Number: K163430
Device Name: Prontosan Wound Gel
Manufacturer: B. Braun Medical, Inc.
Device Classification Name: dressing, wound, drug
Regulation Number:
Classification Product Code: FRO
Date Received: 12/07/2016
Decision Date: 05/23/2017
Regulation Medical Specialty:
Device Name: Prontosan Wound Gel
Manufacturer: B. Braun Medical, Inc.
Device Classification Name: dressing, wound, drug
Regulation Number:
Classification Product Code: FRO
Date Received: 12/07/2016
Decision Date: 05/23/2017
Regulation Medical Specialty:
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- 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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