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U.S. Department of Health and Human Services

Product Classification

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Device actuator, syringe, injector type
Regulation Description Syringe actuator for an injector.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDQF
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type 510(k)
Regulation Number 870.1670
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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