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510(k) K052055

SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 by Smisson-Cartledge Biomedical, LLC — Product Code LGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2006
Date Received
July 29, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Thermal, Infusion Fluid
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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