The following data is part of a premarket notification filed by Allergan Medical Optics with the FDA for Amo Phacoflex Inserter, Foldable Iol Insert Instr.
| Device ID | K930320 |
| 510k Number | K930320 |
| Device Name: | AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR |
| Classification | Lens, Guide, Intraocular |
| Applicant | ALLERGAN MEDICAL OPTICS KM 4,2 RD. 402 Anasco, PR 00610 |
| Contact | Barbara A Niksch |
| Correspondent | Barbara A Niksch ALLERGAN MEDICAL OPTICS KM 4,2 RD. 402 Anasco, PR 00610 |
| Product Code | KYB |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-22 |
| Decision Date | 1994-04-07 |