BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HARGIS SR2 SELF-RETRACTION SYSTEM

    K Number: K921017 · Decision Jul 2, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    656
    Registration Numbers
    656
    Same Product Code
    99
    Applicant Total
    5
    Review Days
    486

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    Basic Information

    Device Name
    HARGIS SR2 SELF-RETRACTION SYSTEM
    K Number
    K921017
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medin Corp.
    Date Received
    March 3, 1992
    Decision Date
    July 2, 1993
    Product Code
    GAD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GAD Retractor

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