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 |