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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Surgical
510(k) Number K930897
Device Name MI-15 EXAM SURGICAL LIGHT
Applicant
Medical Illumination, Inc.
12734 Branford St.
Unit 1 & 2
Arleta,  CA  91331
Applicant Contact HOLLAR
Correspondent
Medical Illumination, Inc.
12734 Branford St.
Unit 1 & 2
Arleta,  CA  91331
Correspondent Contact HOLLAR
Regulation Number878.4580
Classification Product Code
FTD  
Date Received02/22/1993
Decision Date 06/25/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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