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Sakura Steam Sterilizer ASSR-AO12, ASSR-AO12W, ASSR-AO12P and ASSR-A012PW / Skytron Integrity 270 and 270 VP Steam Sterilizer are designed and optimized for use in health care facilities. Sakura Steam Sterilizer ASSR-A012. ASSR-AO12W, ASSR-AO12P and ASSR-AO12PW / Skytron Integrity 270 and 270 VP Steam Sterilizer incorporate high-pressure steam to sterilize non-porous and porous, heat and moisture-stable items and materials used in the health care facilities.

The Sakura Steam Sterilizer ASSR-A012, Sakura Steam Sterilizer ASSR-A012W, Sakura Steam Sterilizer ASSR-A012P, Sakura Steam Sterilizer ASSR-AO12PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizer, are Class II, Product Code FLE Medical Devices as defined by CFR§880.6880 and defined for use in healthcare facilities. The Sakura Steam Sterilizer ASSR-A012. Sakura Steam Sterilizer ASSR-A012W. Sakura Steam Sterilizer ASSR-A012P. Sakura Steam Sterilizer ASSR-AO12PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizer provide efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The sterilizers also dry items that have been sterilized with wet steam.

The Sakura Steam Sterilizer models ASSR-A012, ASSR-A012W, ASSR-A012P, ASSR-A012PW, Skytron Integrity 270 Steam Sterilizer, and Skytron Integrity 270 VP Steam Sterilizer are assessed for safety and effectiveness through non-clinical testing and comparison to a predicate device.

1. A table of acceptance criteria and the reported device performance:

The acceptance criterion for sterilization efficacy is a **Sterility Assurance Level (SAL) of

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