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U.S. Department of Health and Human Services

Product Classification

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Device introducer, syringe needle
Regulation Description Syringe needle introducer.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeKZH
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.6920
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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