The following data is part of a premarket notification filed by Advanced Medical Optics, Inc. with the FDA for Sovereign High Vacuum Pack, Sovereign Compact High Vacuum Pack.
| Device ID | K050648 |
| 510k Number | K050648 |
| Device Name: | SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK |
| Classification | Unit, Phacofragmentation |
| Applicant | ADVANCED MEDICAL OPTICS, INC. 1700 EAST ST. ANDREW PL. Santa Ana, CA 92705 |
| Contact | Pam Schaub |
| Correspondent | Pam Schaub ADVANCED MEDICAL OPTICS, INC. 1700 EAST ST. ANDREW PL. Santa Ana, CA 92705 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-14 |
| Decision Date | 2005-04-05 |
| Summary: | summary |