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U.S. Department of Health and Human Services

Product Classification

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Device indicator, biological sterilization process
Regulation Description Sterilization process indicator.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeFRC
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control Devices (DHT4C)
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
Recognized Consensus Standards
Third Party Review
Accredited Persons
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