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U.S. Department of Health and Human Services

Product Classification

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Device injector, contrast medium, automatic, reprocessed
Regulation Description Angiographic injector and syringe.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeNKP
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Structural Heart Devices Branch (SHDB)
Submission Type 510(k)
Regulation Number 870.1650
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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