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U.S. Department of Health and Human Services

Product Classification

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Device sterilizer, steam
Regulation Description Steam sterilizer.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeFLE
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Infection Control Devices Branch (INCB)
Submission Type 510(k)
Regulation Number 880.6880
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Documents
  • Addendum to: Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities
  • Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM081341.pdf] 
Third Party Review
Accredited Persons

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