The following data is part of a premarket notification filed by Allergan Medical Optics with the FDA for Amo Phacoflex Inserter Disposable Cartridge, And Handpiece.
| Device ID | K941603 |
| 510k Number | K941603 |
| Device Name: | AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE |
| Classification | Lens, Guide, Intraocular |
| Applicant | ALLERGAN MEDICAL OPTICS 9701 JERONIMO RD. Irvine, CA 92618 -2020 |
| Contact | Barbara A Niksch |
| Correspondent | Barbara A Niksch ALLERGAN MEDICAL OPTICS 9701 JERONIMO RD. Irvine, CA 92618 -2020 |
| Product Code | KYB |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-01 |
| Decision Date | 1994-07-06 |