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

    V-ACCI-GUARD(TM) REUSABLE HOLDER

    K Number: K913329 · Decision Aug 23, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    6
    Review Days
    29

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    Basic Information

    Device Name
    V-ACCI-GUARD(TM) REUSABLE HOLDER
    K Number
    K913329
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Safety Products, Inc.
    Date Received
    July 25, 1991
    Decision Date
    August 23, 1991
    Product Code
    FMI
    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
    FMI Needle, Hypodermic, Single Lumen

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