K943379 is an FDA 510(k) clearance for the PHACO TIPS FOR PHACO FRAGMENTATION MACHINES. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on October 11, 1994, 90 days after receiving the submission on July 13, 1994.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K943379 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1994 |
| Decision Date | October 11, 1994 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HQC - Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |