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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Neonatal Phototherapy
510(k) Number K010495
Device Name CENTURA PHOTOTHERAPY SPOTLIGHT
Applicant
MEDICAL ILLUMINATION INTERNATIONAL, INC.
547 LIBRARY ST.
SAN FERNANDO,  CA  91340
Applicant Contact DAVID GLOVER
Correspondent
MEDICAL ILLUMINATION INTERNATIONAL, INC.
547 LIBRARY ST.
SAN FERNANDO,  CA  91340
Correspondent Contact DAVID GLOVER
Regulation Number880.5700
Classification Product Code
LBI  
Date Received02/20/2001
Decision Date 03/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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