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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Thermal, Infusion Fluid
510(k) Number K202461
Device Name ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
Applicant
Smisson-Cartledge Biomedical, LLC
487 Cherry St. - Third St. Tower
Macon,  GA  31201
Applicant Contact Calder Clay III
Correspondent
Regulatory Resources Group, Inc.
111 Laurel Ridge Dr.
Alpharetta,  GA  30004
Correspondent Contact Julie Stephens
Regulation Number880.5725
Classification Product Code
LGZ  
Subsequent Product Codes
FPA   FRN  
Date Received08/27/2020
Decision Date 08/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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