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U.S. Department of Health and Human Services

Product Classification

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Device needle, hypodermic, single lumen
Regulation Description Hypodermic single lumen needle.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeFMI
Premarket Review Reproductive, Gastro-Renal, Urological, General Hospital Device and Human Factors (OHT3)
Drug Delivery and General Hospital Devices and Human Factors (DHT3C)
Submission Type 510(k)
Regulation Number 880.5570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons