The following data is part of a premarket notification filed by Medical Illumination, Inc. with the FDA for Mi-4 Variable Spot Light.
Device ID | K931646 |
510k Number | K931646 |
Device Name: | MI-4 VARIABLE SPOT LIGHT |
Classification | Device, Medical Examination, Ac Powered |
Applicant | MEDICAL ILLUMINATION, INC. 12734 BRANFORD ST. UNIT 1 & 2 Arleta, CA 91331 |
Contact | Hollar |
Correspondent | Hollar MEDICAL ILLUMINATION, INC. 12734 BRANFORD ST. UNIT 1 & 2 Arleta, CA 91331 |
Product Code | KZF |
CFR Regulation Number | 880.6320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-02 |
Decision Date | 1993-08-19 |