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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 K101788
Device Name GIRAFFE OMNIBED
Original Applicant
OHMEDA MEDICAL
8880 gorman rd.
laurel,  MD  20723
Original Contact agata smieja
Regulation Number880.5400
Classification Product Code
FMZ  
Date Received06/25/2010
Decision Date 07/21/2010
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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