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FDA 510(k) Application Details - K192325
Device Classification Name
Warmer, Thermal, Infusion Fluid
More FDA Info for this Device
510(K) Number
K192325
Device Name
Warmer, Thermal, Infusion Fluid
Applicant
Life Warmer, Inc.
4813 Keller Springs Rd
Addison, TX 75001 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
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/27/2019
Decision Date
10/18/2019
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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