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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 K052055
Device Name SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200
Applicant
Smisson-Cartledge Biomedical, LLC
111 Laurel Ridge Dr.
Alpharetta,  GA  30004
Applicant Contact JULIE STEPHENS
Correspondent
Smisson-Cartledge Biomedical, LLC
111 Laurel Ridge Dr.
Alpharetta,  GA  30004
Correspondent Contact JULIE STEPHENS
Regulation Number880.5725
Classification Product Code
LGZ  
Subsequent Product Codes
FPA   FRN  
Date Received07/29/2005
Decision Date 10/26/2006
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
Recalls CDRH Recalls
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