K003670 is an FDA 510(k) clearance for the PATIENT DRAPE, SURGICAL. 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 January 26, 2001, 59 days after receiving the submission on November 28, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K003670 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 2000 |
| Decision Date | January 26, 2001 |
| Days to Decision | 59 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 |