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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Device, Medical Examination, Ac Powered
510(k) Number K925710
Device Name M.E.D. 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 Number880.6320
Classification Product Code
KZF  
Date Received11/12/1992
Decision Date 06/04/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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