K780565 is an FDA 510(k) clearance for the SUTURELESS SKIN CLOSURE. This device is classified as a Strip, Adhesive, Closure, Skin (Class I - General Controls, product code FPX).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 7, 1978, 92 days after receiving the submission on April 6, 1978.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5240.
| 510(k) Number | K780565 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 1978 |
| Decision Date | July 07, 1978 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | FPX — Strip, Adhesive, Closure, Skin |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5240 |