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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 DRIVE
ALPHARETTA,  GA  30004
Applicant Contact JULIE STEPHENS
Correspondent
SMISSON-CARTLEDGE BIOMEDICAL LLC
111 LAUREL RIDGE DRIVE
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
Recalls CDRH Recalls
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