The following data is part of a premarket notification filed by Abbott Medical Optics Inc with the FDA for Amo Whitestar Signature Phacoemulsification System.
| Device ID | K111697 |
| 510k Number | K111697 |
| Device Name: | AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM |
| Classification | Unit, Phacofragmentation |
| Applicant | ABBOTT MEDICAL OPTICS INC 1700 E. ST. ANDREW PLACE Santa Ana, CA 92705 |
| Contact | Ophelia Biggs |
| Correspondent | Ophelia Biggs ABBOTT MEDICAL OPTICS INC 1700 E. ST. ANDREW PLACE Santa Ana, CA 92705 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-17 |
| Decision Date | 2011-09-27 |
| Summary: | summary |