The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Prontosan Wound Gel.
| Device ID | K163430 |
| 510k Number | K163430 |
| Device Name: | Prontosan Wound Gel |
| Classification | Dressing, Wound, Drug |
| Applicant | B. Braun Medical, Inc. 901 Marcon Boulevard Allentown, PA 18109 -9341 |
| Contact | Nancy Skocypec |
| Correspondent | Nancy Skocypec B. Braun Medical, Inc. 901 Marcon Boulevard Allentown, PA 18109 -9341 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-12-07 |
| Decision Date | 2017-05-23 |
| Summary: | summary |