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FDA 510(k) Application Details - K103525
Device Classification Name
Incubator, Neonatal Transport
More FDA Info for this Device
510(K) Number
K103525
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
More FDA Info for this Regulation Number
Classification Product Code
FPL
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More FDA Info for this Product Code
Date Received
12/01/2010
Decision Date
05/11/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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