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 |