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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 General Hospital
Product CodeDQF
Premarket Review Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 870.1670
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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