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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name incubator, neonatal
510(k) Number K040068
Device Name BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
Original Applicant
OHMEDA MEDICAL
8880 gorman rd.
laurel,  MD  20723
Original Contact alberto f profumo
Regulation Number880.5400
Classification Product Code
FMZ  
Subsequent Product Code
HJM  
Date Received01/20/2004
Decision Date 04/16/2004
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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