The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Prontosan Wound Gel X.
| Device ID | K130857 |
| 510k Number | K130857 |
| Device Name: | PRONTOSAN WOUND GEL X |
| Classification | Dressing, Wound, Drug |
| Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Contact | Nancy Skocypec |
| Correspondent | Nancy Skocypec B. BRAUN MEDICAL, INC. 901 MARCON BLVD. 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 | 2013-03-28 |
| Decision Date | 2013-10-08 |
| Summary: | summary |