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510(k) Data Aggregation

    K Number
    K132439
    Device Name
    SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER
    Date Cleared
    2014-01-06

    (154 days)

    Product Code
    Regulation Number
    880.6880
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAKURA SEIKI CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K122774
    Device Name
    SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG
    Date Cleared
    2013-05-09

    (241 days)

    Product Code
    Regulation Number
    880.6880
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAKURA SEIKI CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sakura Steam Sterilizer ASSV-AH06 / Skytron Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E / Skytron Integrity 175 SG Steam Sterilizers are designed and optimized for use in health care facilities. Sakura Steam Sterilizer ASSV-AH06 / Skytron Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E / Skytron Integrity 175 SG Steam Sterilizers incorporate high-pressure steam to sterilize non-porous and porous, heat and moisture-stable items and materials used in the health care facilities.
    Device Description
    Sakura Steam Sterilizer ASSV-AH06, SKYTRON Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E and SKYTRON Integrity 175 SG Steam Sterilizers are Class II, Product Code FLE Medical Devices as defined by CFR§880.6880 and defined for use in healthcare facilities. Sakura Steam Sterilizer ASSV-AH06, SKYTRON Integrity 175 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AH06E and SKYTRON Integrity 175 SG Steam Sterilizers 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.
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    K Number
    K120149
    Device Name
    SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA
    Date Cleared
    2012-05-08

    (111 days)

    Product Code
    Regulation Number
    880.6880
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAKURA SEIKI CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sakura Steam Sterilizer ASSV-AB-09 / Skytron Integrity 215 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AB09E / Skytron Integrity 215 SG Steam Sterilizer are designed and optimized for use in health care facilities. Sakura Steam Sterilizer ASSV-AB-09 / Skytron Integrity 215 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AB09E / Skytron Integrity 215 SG 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.
    Device Description
    The SKYTRON Integrity 215 Steam Sterilizer. SKYTRON Integrity 215 SG Steam Sterilizer, Sakura Steam Stenlizer ASSV-AB09, Sakura Steam Sterilizer ASSV-AB09E Steam Sterilizers are Class II, Product Code FLE Medical Devices as defined by CFR§880.6880 and defined for use in healthcare facilities. The SKYTRON Integrity 215 Steam Sterilizer, SKYTRON Integrity 215 SG Steam Sterilizer, Sakura Steam Sterilizer ASSV-AB09, Sakura Steam Sterilizer ASSV-AB09E Steam Sterilizers 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.
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