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    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG

    K Number: K122774 · Decision May 9, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    183
    Applicant Total
    3
    Review Days
    241

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    Basic Information

    Device Name
    SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG
    K Number
    K122774
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6880
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sakura Seiki Co., Ltd.
    Date Received
    September 10, 2012
    Decision Date
    May 9, 2013
    Product Code
    FLE
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FLE Sterilizer, Steam

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    Other Clearances by Sakura Seiki Co., Ltd.

    K Number Device Name
    K132439 SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER
    K120149 SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA