The following data is part of a premarket notification filed by Advanced Medical Optics, Inc. with the FDA for One Series Ultra Cartridge, Model 1vipr30.
| Device ID | K081545 |
| 510k Number | K081545 |
| Device Name: | ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 |
| Classification | Lens, Guide, Intraocular |
| Applicant | ADVANCED MEDICAL OPTICS, INC. 1700 EAST ST. ANDREW PL. Santa Ana, CA 92705 |
| Contact | Kim Regis |
| Correspondent | Kim Regis ADVANCED MEDICAL OPTICS, INC. 1700 EAST ST. ANDREW PL. Santa Ana, CA 92705 |
| Product Code | KYB |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-02 |
| Decision Date | 2008-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15050474540320 | K081545 | 000 |
| 15050474534602 | K081545 | 000 |