The following data is part of a premarket notification filed by Allergan Medical Optics with the FDA for Phaco-injector(tm) Intraocular Lens Implant Instr.
| Device ID | K893199 |
| 510k Number | K893199 |
| Device Name: | PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR |
| Classification | Forceps, Ophthalmic |
| Applicant | ALLERGAN MEDICAL OPTICS KM 4,2 RD. 402 Anasco, PR 00610 |
| Contact | Paul S Kramsky |
| Correspondent | Paul S Kramsky ALLERGAN MEDICAL OPTICS KM 4,2 RD. 402 Anasco, PR 00610 |
| Product Code | HNR |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-26 |
| Decision Date | 1989-06-16 |