K061716 is an FDA 510(k) clearance for the PRESTIGE AMERITECH FACE MASK. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Prestige Ameritech (Fort Worth, US). The FDA issued a Cleared decision on August 14, 2006, 56 days after receiving the submission on June 19, 2006.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K061716 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 2006 |
| Decision Date | August 14, 2006 |
| Days to Decision | 56 days |
| Submission Type | Abbreviated |
| 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 |