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U.S. Department of Health and Human Services

Product Classification

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Device system, thermal regulating
Regulation Description Thermal regulating system.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDWJ
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type 510(k)
Regulation Number 870.5900
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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