K011422 is an FDA 510(k) clearance for the SURGICAL DRAPES. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on July 10, 2001, 62 days after receiving the submission on May 9, 2001.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K011422 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2001 |
| Decision Date | July 10, 2001 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KKX — Drape, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |