FDA 510(k), K161623, Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
FDA 510(k), K161623, Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
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510(K) Number: K161623
Device Name: Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
Manufacturer: B. Braun Medical Inc.
Device Classification Name: Dressing, Wound, Drug
Regulation Number:
Classification Product Code: FRO
Date Received: 06/13/2016
Decision Date: 11/10/2016
Regulation Medical Specialty:
Device Name: Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
Manufacturer: B. Braun Medical Inc.
Device Classification Name: Dressing, Wound, Drug
Regulation Number:
Classification Product Code: FRO
Date Received: 06/13/2016
Decision Date: 11/10/2016
Regulation Medical Specialty:
- 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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