K041653 is an FDA 510(k) clearance for the COMPEL 1-PLY 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 July 1, 2005, 379 days after receiving the submission on June 17, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K041653 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2004 |
| Decision Date | July 01, 2005 |
| Days to Decision | 379 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |