K872757 is an FDA 510(k) clearance for the OPSITE SPECIALITY DRAPES. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Smith & Nephew, Inc. (Massillon, US). The FDA issued a Cleared decision on July 28, 1987, 15 days after receiving the submission on July 13, 1987.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K872757 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1987 |
| Decision Date | July 28, 1987 |
| Days to Decision | 15 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 |