The following data is part of a premarket notification filed by Medical Illumination, Inc. with the FDA for Illuminator Iv Minor Surgery Light.
Device ID | K922279 |
510k Number | K922279 |
Device Name: | ILLUMINATOR IV MINOR SURGERY LIGHT |
Classification | Light, Surgical, Endoscopic |
Applicant | MEDICAL ILLUMINATION, INC. 12734 BRANFORD ST. UNIT 1 & 2 Arleta, CA 91331 |
Product Code | FSW |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-15 |
Decision Date | 1992-09-02 |