The following data is part of a premarket notification filed by Medical Instrument Development Laboratories, Inc. with the FDA for Infusion Aspiration Vitrectomy Sys.
| Device ID | K843391 |
| 510k Number | K843391 |
| Device Name: | INFUSION ASPIRATION VITRECTOMY SYS |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. P.O. BOX 1737 San Leandro , CA 94577 - |
| Contact | Wang |
| Correspondent | Wang MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. P.O. BOX 1737 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 | 1984-08-29 |
| Decision Date | 1984-12-19 |