The following data is part of a premarket notification filed by Abbott Medical Optics Inc with the FDA for One Series Ultra Cartridge, The Unfolder Platinum 1 Series.
| Device ID | K143434 |
| 510k Number | K143434 |
| Device Name: | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | ABBOTT MEDICAL OPTICS INC 1700 EAST SAINT ANDREW PL Santa Ana, CA 92705 |
| Contact | Nooshin Azizi |
| Correspondent | Nooshin Azizi ABBOTT MEDICAL OPTICS INC 1700 EAST SAINT ANDREW PL Santa Ana, CA 92705 |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-01 |
| Decision Date | 2015-05-06 |
| Summary: | summary |