K891051 is an FDA 510(k) clearance for the SURGICAL FACE MASK-EAR LOOP. This device is classified as a Mask, Surgical (Class II — Special Controls, product code FXX).
Submitted by Dispomed, Inc. (Burbank, US). The FDA issued a Cleared decision on April 12, 1989, 44 days after receiving the submission on February 27, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K891051 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 1989 |
| Decision Date | April 12, 1989 |
| Days to Decision | 44 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 |