The following data is part of a premarket notification filed by Allergan Humphrey with the FDA for Model 3000 Ophthalmic Surgical System.
| Device ID | K872312 |
| 510k Number | K872312 |
| Device Name: | MODEL 3000 OPHTHALMIC SURGICAL SYSTEM |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | ALLERGAN HUMPHREY 3081 TEAGARDEN ST. San Leandro, CA 94577 |
| Contact | Berry Dodd |
| Correspondent | Berry Dodd ALLERGAN HUMPHREY 3081 TEAGARDEN ST. San Leandro, CA 94577 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-14 |
| Decision Date | 1987-07-15 |