K781959 is an FDA 510(k) clearance for the SURGICAL GOWNS, SHEETS. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Convertors (Walker, US). The FDA issued a Cleared decision on January 10, 1979, 50 days after receiving the submission on November 21, 1978.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K781959 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 1978 |
| Decision Date | January 10, 1979 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |