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U.S. Department of Health and Human Services

Product Classification

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Device needle, hypodermic, single lumen, reprocessed
Regulation Description Hypodermic single lumen needle.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeNKK
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 880.5570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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