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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, surgical, ceiling mounted
510(k) Number K140812
Device Name MI-750 PROCEDURAL/MINOR SURGICAL LIGHT
Applicant
MEDICAL ILLUMINATION INTERNATIONAL, INC.
547 LIBRARY ST.
SAN FERNANDO,  CA  91340
Applicant Contact ROBERT HESS
Correspondent
MEDICAL ILLUMINATION INTERNATIONAL, INC.
547 LIBRARY ST.
SAN FERNANDO,  CA  91340
Correspondent Contact ROBERT HESS
Regulation Number878.4580
Classification Product Code
FSY  
Date Received04/01/2014
Decision Date 08/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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