K062899 is an FDA 510(k) clearance for the MICROTEK MEDICAL SURGICAL GOWN/TOGA. This device is classified as a Gown, Surgical (Class II - Special Controls, product code FYA).
Submitted by Microtek Medical, Inc. (Columbus, US). The FDA issued a Cleared decision on January 25, 2007, 120 days after receiving the submission on September 27, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K062899 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2006 |
| Decision Date | January 25, 2007 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYA — Gown, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |