K882402 is an FDA 510(k) clearance for the RETRACTIVE INCISION MICROMETER (RIM) GUAGE. This device is classified as a Knife, Ophthalmic (Class I - General Controls, product code HNN).
Submitted by Optical Center (Oxnard, US). The FDA issued a Cleared decision on August 22, 1988, 73 days after receiving the submission on June 10, 1988.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.
| 510(k) Number | K882402 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 1988 |
| Decision Date | August 22, 1988 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HNN — Knife, Ophthalmic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4350 |