K894516 is an FDA 510(k) clearance for the VISOSHIELD(TM), SURGICAL EYE PROTECTOR. This device is classified as a Mask, Surgical (Class II - Special Controls, product code FXX).
Submitted by Polamedco, Inc. (Inglewood, US). The FDA issued a Cleared decision on September 12, 1989, 55 days after receiving the submission on July 19, 1989.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K894516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1989 |
| Decision Date | September 12, 1989 |
| Days to Decision | 55 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 |