The following data is part of a premarket notification filed by Gorbec Pharmaceutical Services, Inc. with the FDA for Barirep.
| Device ID | K100839 |
| 510k Number | K100839 |
| Device Name: | BARIREP |
| Classification | Dressing, Wound, Drug |
| Applicant | GORBEC PHARMACEUTICAL SERVICES, INC. 2445 SOUTH ALSTON AVENUE Durham, NC 27713 |
| Contact | Matthew Popp |
| Correspondent | Matthew Popp GORBEC PHARMACEUTICAL SERVICES, INC. 2445 SOUTH ALSTON AVENUE Durham, NC 27713 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-24 |
| Decision Date | 2010-05-11 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BARIREP 85019087 3949210 Dead/Cancelled |
STAYMA CONSULTING SERVICES, LLC 2010-04-21 |