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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
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] 
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