The following data is part of a premarket notification filed by Medical Instrument Development Laboratories, Inc. with the FDA for Mid Labs Twin Illuminator.
Device ID | K932131 |
510k Number | K932131 |
Device Name: | MID LABS TWIN ILLUMINATOR |
Classification | Source, Carrier, Fiberoptic Light |
Applicant | MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 2235 POLVOROSA AVE. SUITE 200 San Leandro, CA 94577 |
Contact | David E Chen |
Correspondent | David E Chen MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 2235 POLVOROSA AVE. SUITE 200 San Leandro, CA 94577 |
Product Code | EQH |
CFR Regulation Number | 874.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-03 |
Decision Date | 1994-04-01 |