K872362 is an FDA 510(k) clearance for the FRIGITRONICS ACC-1000 CAPSULE CUTTER. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Frigitronics of Connecticut, Inc. (Shelton, US). The FDA issued a Cleared decision on July 27, 1987, 39 days after receiving the submission on June 18, 1987.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K872362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 1987 |
| Decision Date | July 27, 1987 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HQC — Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |