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U.S. Department of Health and Human Services

Product Classification

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Device tourniquet, automatic rotating
Regulation Description Automatic rotating tourniquet.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDRP
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Peripheral Interventional Devices Branch (PIDB)
Submission Type 510(k)
Regulation Number 870.5925
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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