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FDA 510(k) Application Details - K081399
Device Classification Name
Incubator, Neonatal Transport
More FDA Info for this Device
510(K) Number
K081399
Device Name
Incubator, Neonatal Transport
Applicant
INTERNATIONAL BIOMEDICAL, LTD.
8508 CROSS PARK DR.
AUSTIN, TX 78754 US
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Contact
AMY PIEPER
Other 510(k) Applications for this Contact
Regulation Number
880.5410
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Classification Product Code
FPL
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More FDA Info for this Product Code
Date Received
05/19/2008
Decision Date
06/06/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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