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FDA 510(k) Application Details - K181775
Device Classification Name
Warmer, Thermal, Infusion Fluid
More FDA Info for this Device
510(K) Number
K181775
Device Name
Warmer, Thermal, Infusion Fluid
Applicant
Life Warmer, Inc.
840 F. Avenue Suite 104
Plano, TX 75074 US
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Contact
John Pettini
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
LGZ
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More FDA Info for this Product Code
Date Received
07/03/2018
Decision Date
01/28/2019
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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