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FDA 510(k) Application Details - K150404
Device Classification Name
Warmer, Thermal, Infusion Fluid
More FDA Info for this Device
510(K) Number
K150404
Device Name
Warmer, Thermal, Infusion Fluid
Applicant
Quality in Flow Ltd.
3A Bazel St. POB 10159
Petach Tikva 49002 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
02/18/2015
Decision Date
06/23/2016
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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