K944863 is an FDA 510(k) clearance for the COMPEL SURGICALDRAPES. 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 28, 1995, 148 days after receiving the submission on October 3, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K944863 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 1994 |
| Decision Date | February 28, 1995 |
| Days to Decision | 148 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 |