The following data is part of a premarket notification filed by Medical Instrument Development Laboratories, Inc. with the FDA for I/a Handpiece.
| Device ID | K850857 |
| 510k Number | K850857 |
| Device Name: | I/A HANDPIECE |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 2235 POLVOROSA AVE. SUITE 200 San Leandro, CA 94577 |
| Contact | William T George |
| Correspondent | William T George MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 2235 POLVOROSA AVE. SUITE 200 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 | 1985-03-01 |
| Decision Date | 1985-03-29 |