The following data is part of a premarket notification filed by Precision Medical Instruments, Inc. with the FDA for Vitrectomy Integrating Tray Ocutome/frag.
| Device ID | K791212 |
| 510k Number | K791212 |
| Device Name: | VITRECTOMY INTEGRATING TRAY OCUTOME/FRAG |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | PRECISION MEDICAL INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-03 |
| Decision Date | 1979-08-10 |