K945371 is an FDA 510(k) clearance for the COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Standard Textile Co., Inc. (Cincinnati, US). The FDA issued a Cleared decision on April 27, 1995, 176 days after receiving the submission on November 2, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K945371 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1994 |
| Decision Date | April 27, 1995 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |