K891161 is an FDA 510(k) clearance for the VITRECTOMY PACK #J120. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by O.R. Specialties, Inc. (Tuscaloosa, US). The FDA issued a Cleared decision on May 26, 1989, 81 days after receiving the submission on March 6, 1989.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K891161 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 1989 |
| Decision Date | May 26, 1989 |
| Days to Decision | 81 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 |