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

    ACCI-GUARD REUSABLE HOLDER

    K Number: K895075 · Decision Oct 31, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    6
    Review Days
    78

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    Basic Information

    Device Name
    ACCI-GUARD REUSABLE HOLDER
    K Number
    K895075
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Medical Safety Products, Inc.
    Date Received
    August 14, 1989
    Decision Date
    October 31, 1989
    Product Code
    FMI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMI Needle, Hypodermic, Single Lumen

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