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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 Center for Biologics Evaluation & Research (CBER)
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 Standards
Guidance Documents
  • Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles
  • Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes
  • Neonatal and Neonatal Transport Incubators - Premarket Notifications; Final
Third Party Review
Accredited Persons

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