K780627 is an FDA 510(k) clearance for the SURG-O-PAK, GOWNS, SHEETS, AND TOWELS. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Convertors (Mchenry, US). The FDA issued a Cleared decision on July 11, 1979, 453 days after receiving the submission on April 14, 1978.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K780627 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 1978 |
| Decision Date | July 11, 1979 |
| Days to Decision | 453 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 |