BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS

    K Number: K951703 · Decision Jun 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    77

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    Basic Information

    Device Name
    TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS
    K Number
    K951703
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Products For Medicine
    Date Received
    April 12, 1995
    Decision Date
    June 28, 1995
    Product Code
    LRT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LRT Indicator, Sterilization

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LRT), ordered by most recent decision date.

    TST CONTROL INTEGRATOR FOR STEAM STERILIZERS

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    CROSS-CHECKS

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    STERILIZATION INDICATOR FOR FLASH STERILIZATION

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    Other Clearances by Products For Medicine

    K Number Device Name
    K963227 WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175
    K955510 X6000D SILENT SUN LIGHT SOURCE
    K953089 I-SPOUSE
    K951704 NON-WOVEN FILTER PAPER FOR STEAM AND GAS STERILIZATION
    K883658 I-SPOSE EYE SHIELD