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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 K120820
Device Name GIRAFFE BLUE SPOT PT LITE
Applicant
LUMITEX, INC.
8443 dow cir.
strongsville,  OH  44136
Contact david felty
Regulation Number880.5700
Classification Product Code
LBI  
Date Received03/19/2012
Decision Date 06/08/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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