The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Prontosan Antimicrobial Wound Gel.
Device ID | K101882 |
510k Number | K101882 |
Device Name: | PRONTOSAN ANTIMICROBIAL WOUND GEL |
Classification | Dressing, Wound, Drug |
Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
Contact | Matthew J Homa |
Correspondent | Matthew J Homa 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 | 2010-07-06 |
Decision Date | 2010-11-03 |
Summary: | summary |