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 |