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U.S. Department of Health and Human Services

Product Classification

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Device indicator, biological, liquid chemical sterilization process
Regulation Description Sterilization process indicator.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeMRB
Premarket Review Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic and Reconstructive Surgery (DHT4B)
Submission Type 510(k)
Regulation Number 880.2800
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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