K063043 is an FDA 510(k) clearance for the SURGICAL FACE MASK, TYPE: TIE-ON, EAR-LOOP. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Modern Healthcare Corp. (Hsin-Chu City, TW). The FDA issued a Cleared decision on March 21, 2007, 169 days after receiving the submission on October 3, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K063043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2006 |
| Decision Date | March 21, 2007 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FXX - Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |