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U.S. Department of Health and Human Services

Product Classification

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Device piston syringe lever
Definition Controlled compression of a piston syringe
Physical State Syringe holder with proximal advancement mechanism which places pressure through means of a screw lever and manual proximal screw-down control wheel
Technical Method Precision compression to proximal end of a syringe through means of a lever.
Target Area Urology
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeQBL
Premarket Review GastroRenal, ObGyn, General Hospital, and Urology Devices (OHT3)
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
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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