K791983 is an FDA 510(k) clearance for the SPATULA'S #'S 7618,7248,7240,7242,5108. This device is classified as a Spatula, Ophthalmic (Class I - General Controls, product code HND).
Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1979, 9 days after receiving the submission on September 25, 1979.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K791983 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1979 |
| Decision Date | October 04, 1979 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HND — Spatula, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |