K872758 is an FDA 510(k) clearance for the THEATRE GOWNS. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Smith & Nephew, Inc. (Massillon, US). The FDA issued a Cleared decision on July 31, 1987, 18 days after receiving the submission on July 13, 1987.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K872758 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1987 |
| Decision Date | July 31, 1987 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |