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U.S. Department of Health and Human Services

Product Classification

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Device injector and syringe, angiographic, balloon inflation, reprocessed
Regulation Description Angiographic injector and syringe.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeNKU
Premarket Review Office of Cardiovascular Devices (OHT2)
Coronary and Peripheral Interventional Devices (DHT2C)
Submission Type 510(k)
Regulation Number 870.1650
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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