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U.S. Department of Health and Human Services

Product Classification

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Device sterilant, medical devices
Regulation Description Liquid chemical sterilants/high level disinfectants.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeMED
Submission Type 510(k)
Regulation Number 880.6885
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants and High Level Disinfectants; Final
Third Party Review
Accredited Persons

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