K050648 is an FDA 510(k) clearance for the SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by Advanced Medical Optics, Inc. (Santa Ana, US). The FDA issued a Cleared decision on April 5, 2005, 22 days after receiving the submission on March 14, 2005.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K050648 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2005 |
| Decision Date | April 05, 2005 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQC — Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |