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510(k) K202461

ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System by Smisson-Cartledge Biomedical, LLC — Product Code LGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2022
Date Received
August 27, 2020
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

Other clearances by Smisson-Cartledge Biomedical, LLC

  • K052055 — SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 (October 26, 2006)

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