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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 K020543
Device Name OHMEDA MEDICAL GIRAFFE OMNIBED
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
FMT  
Date Received02/19/2002
Decision Date 05/09/2002
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
Recalls CDRH Recalls
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