K012807 is an FDA 510(k) clearance for the MODIFICATION TO: 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 October 11, 2001, 50 days after receiving the submission on August 22, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K012807 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2001 |
| Decision Date | October 11, 2001 |
| Days to Decision | 50 days |
| Submission Type | Special |
| 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 |