K923811 is an FDA 510(k) clearance for the COMPEL SURGICAL DRAPES. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Standard Textile Co., Inc. (Cincinnati, US). The FDA issued a Cleared decision on February 23, 1993, 209 days after receiving the submission on July 29, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K923811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 1992 |
| Decision Date | February 23, 1993 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |