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U.S. Department of Health and Human Services

Product Classification

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Device syringe, antistick
Regulation Description Piston syringe.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeMEG
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 880.5860
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
Recognized Consensus Standards
Guidance Documents
Third Party Review
Accredited Persons
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