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FDA 510(k) Application Details - K061280
Device Classification Name
Incubator, Neonatal
More FDA Info for this Device
510(K) Number
K061280
Device Name
Incubator, Neonatal
Applicant
NEOFORCE GROUP, INC.
5985 HONEY HOLLOW RD.
DOYLESTOWN, PA 18901 US
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Contact
MARY STANIEWICZ
Other 510(k) Applications for this Contact
Regulation Number
880.5400
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Classification Product Code
FMZ
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More FDA Info for this Product Code
Date Received
05/08/2006
Decision Date
06/27/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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