The following data is part of a premarket notification filed by Medical Instrument Development Laboratories, Inc. with the FDA for Univit Probe.
| Device ID | K950287 |
| 510k Number | K950287 |
| Device Name: | UNIVIT PROBE |
| Classification | Instrument, Vitreous Aspiration And Cutting, Battery-powered |
| Applicant | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 14477 CATALINA ST. San Leandro, CA 94577 |
| Contact | Carl C Wang |
| Correspondent | Carl C Wang MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 14477 CATALINA ST. San Leandro, CA 94577 |
| Product Code | HKP |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-24 |
| Decision Date | 1995-04-10 |