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FDA 510(k) Application Details - K171215
Device Classification Name
Warmer, Thermal, Infusion Fluid
More FDA Info for this Device
510(K) Number
K171215
Device Name
Warmer, Thermal, Infusion Fluid
Applicant
Quality In Flow Ltd.
Kibutz Einat POB 29
Kibutz Einat 4880500 IL
Other 510(k) Applications for this Company
Contact
Neta Sherman
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LGZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/25/2017
Decision Date
09/27/2017
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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