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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
Applicant
OHMEDA MEDICAL
8880 GORMAN RD.
LAUREL,  MD  20723
Applicant Contact ALBERTO F PROFUMO
Correspondent
OHMEDA MEDICAL
8880 GORMAN RD.
LAUREL,  MD  20723
Correspondent Contact ALBERTO F PROFUMO
Regulation Number880.5400
Classification Product Code
FMZ  
Subsequent Product Code
HJM  
Date Received01/14/2004
Decision Date 04/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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