K782008 is an FDA 510(k) clearance for the DRESSING, ENVIRON WOUND. This device is classified as a Bandage, Liquid (Class I - General Controls, product code KMF).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 14, 1979, 164 days after receiving the submission on December 1, 1978.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5090.
| 510(k) Number | K782008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 1978 |
| Decision Date | May 14, 1979 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KMF — Bandage, Liquid |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5090 |