The following data is part of a premarket notification filed by Medical Instrument Development Laboratories, Inc. with the FDA for Automated Intraocular Scissors.
Device ID | K842471 |
510k Number | K842471 |
Device Name: | AUTOMATED INTRAOCULAR SCISSORS |
Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
Applicant | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. P.O. BOX 1737 San Leandro , CA 94577 - |
Contact | William T George |
Correspondent | William T George 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 | 1984-06-25 |
Decision Date | 1984-11-21 |