K780169 is an FDA 510(k) clearance for the MASK, SURGICAL. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Convertors (Mchenry, US). The FDA issued a Cleared decision on February 13, 1978, 11 days after receiving the submission on February 2, 1978.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K780169 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 1978 |
| Decision Date | February 13, 1978 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FXX — Mask, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4040 |