K822125 is an FDA 510(k) clearance for the MODEL 57000 NASO-CONJUNCTIVA ISOL. MASK..
Submitted by Welch Allyn, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 27, 1982, 39 days after receiving the submission on July 19, 1982.
This device falls under the Ophthalmic FDA review panel.
| 510(k) Number | K822125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1982 |
| Decision Date | August 27, 1982 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | — |
| Device Class | — |