K875194 is an FDA 510(k) clearance for the KLEENSPEC DISPOSABLE FACE SHIELD, MODEL 57001. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on January 22, 1988, 36 days after receiving the submission on December 17, 1987.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K875194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 1987 |
| Decision Date | January 22, 1988 |
| Days to Decision | 36 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 |