K801699 is an FDA 510(k) clearance for the ETHICON RETRACTION TAPE. This device is classified as a Retractor (Class I - General Controls, product code GAD).
Submitted by Ethicon, Inc. (Walker, US). The FDA issued a Cleared decision on September 26, 1980, 65 days after receiving the submission on July 23, 1980.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K801699 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 1980 |
| Decision Date | September 26, 1980 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GAD — Retractor |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |