ZENIEVA
Dressing, Wound, Hydrogel Without Drug And/or Biologic
GORBEC PHARMACEUTICAL SERVICES, INC.
The following data is part of a premarket notification filed by Gorbec Pharmaceutical Services, Inc. with the FDA for Zenieva.
Pre-market Notification Details
| Device ID | K073246 |
| 510k Number | K073246 |
| Device Name: | ZENIEVA |
| Classification | Dressing, Wound, Hydrogel Without Drug And/or Biologic |
| Applicant | GORBEC PHARMACEUTICAL SERVICES, INC. 2445 SOUTH ALSTON AVENUE Durham, NC 27713 |
| Contact | Sandra R Kircus |
| Correspondent | Sandra R Kircus GORBEC PHARMACEUTICAL SERVICES, INC. 2445 SOUTH ALSTON AVENUE Durham, NC 27713 |
| Product Code | NAE |
| CFR Regulation Number | 878.4022 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-19 |
| Decision Date | 2008-07-23 |
| Summary: | summary |
Trademark Results [ZENIEVA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZENIEVA 77594247 3740952 Dead/Cancelled |
BKK PHARMACEUTICALS, LLC 2008-10-16 |
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