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FDA 510(k) Application Details - K202461
Device Classification Name
Warmer, Thermal, Infusion Fluid
More FDA Info for this Device
510(K) Number
K202461
Device Name
Warmer, Thermal, Infusion Fluid
Applicant
Smisson-Cartledge Biomedical LLC
487 Cherry Street - Third Street Tower
Macon, GA 31201 US
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Contact
Calder Clay III
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
08/27/2020
Decision Date
08/12/2022
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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