The following data is part of a premarket notification filed by Promex, Inc. with the FDA for Automated Vitrectomy Device.
| Device ID | K961078 |
| 510k Number | K961078 |
| Device Name: | AUTOMATED VITRECTOMY DEVICE |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | PROMEX, INC. 1125 BROOKSIDE AVE. SUITE G500 Indianapolis, IN 46202 |
| Contact | Jospeh L Mark |
| Correspondent | Jospeh L Mark PROMEX, INC. 1125 BROOKSIDE AVE. SUITE G500 Indianapolis, IN 46202 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-18 |
| Decision Date | 1996-06-14 |