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U.S. Department of Health and Human Services

Product Classification

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Device sterilization wrap containers, trays, cassettes & other accessories
Regulation Description Sterilization wrap.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeKCT
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Infection Control Devices Branch (INCB)
Submission Type 510(k)
Regulation Number 880.6850
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons