The following data is part of a premarket notification filed by Allergan Medical Optics with the FDA for Multitome Model 1000, Vitrectomy Driving System.
| Device ID | K911998 |
| 510k Number | K911998 |
| Device Name: | MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | ALLERGAN MEDICAL OPTICS KM 4,2 RD. 402 Anasco, PR 00610 |
| Contact | John E Sage |
| Correspondent | John E Sage ALLERGAN MEDICAL OPTICS KM 4,2 RD. 402 Anasco, PR 00610 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-29 |
| Decision Date | 1991-07-26 |