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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
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control Devices (DHT4C)
Submission Type 510(k)
Regulation Number 880.6885
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Guidance Document
Third Party Review
Accredited Persons
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