K060200 is an FDA 510(k) clearance for the MICROTEK MEDICAL WARMING DRAPE. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).
Submitted by Microtek Medical, Inc. (Columbus, US). The FDA issued a Cleared decision on May 31, 2006, 125 days after receiving the submission on January 26, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K060200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 2006 |
| Decision Date | May 31, 2006 |
| Days to Decision | 125 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 |