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

    SUTURE REMOVAL KIT

    K Number: K920340 · Decision Apr 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    8
    Review Days
    90

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    Basic Information

    Device Name
    SUTURE REMOVAL KIT
    K Number
    K920340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Medikmark, Inc.
    Date Received
    January 24, 1992
    Decision Date
    April 23, 1992
    Product Code
    KKX
    Advisory Committee
    General, Plastic Surgery
    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
    KKX Drape, Surgical, Antimicrobial

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