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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, fiberoptic
510(k) Number K100388
Device Name 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS
Applicant
MEDICAL ILLUMINATION INTERNATIONAL, INC.
547 LIBRARY ST.
SAN FERNANDO,  CA  91340
Applicant Contact WAYNE GEROW
Correspondent
MEDICAL ILLUMINATION INTERNATIONAL, INC.
547 LIBRARY ST.
SAN FERNANDO,  CA  91340
Correspondent Contact WAYNE GEROW
Regulation Number878.4580
Classification Product Code
FST  
Date Received02/16/2010
Decision Date 06/22/2010
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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