K082865 is an FDA 510(k) clearance for the MODIFICATION TO ZENIEVA. This device is classified as a Dressing, Wound, Hydrogel Without Drug And/or Biologic (Class I - General Controls, product code NAE).
Submitted by Gorbec Pharmaceutical Services, Inc. (Durham, US). The FDA issued a Cleared decision on October 23, 2008, 24 days after receiving the submission on September 29, 2008.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4022.
| 510(k) Number | K082865 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2008 |
| Decision Date | October 23, 2008 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NAE — Dressing, Wound, Hydrogel Without Drug And/or Biologic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4022 |