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FDA 510(k) Application Details - K150484
Device Classification Name
Warmer, Thermal, Infusion Fluid
More FDA Info for this Device
510(K) Number
K150484
Device Name
Warmer, Thermal, Infusion Fluid
Applicant
Creche Innovations
17745 Metcalf
One Penguin Plaza
Stilwell, KS 66085 US
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Contact
REBECCA P PINE
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LGZ
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More FDA Info for this Product Code
Date Received
02/24/2015
Decision Date
07/09/2015
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
N
Expedited Review
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