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

    XTRACETEZE SURGICAL SKIN STAPLE REMOVER 2001

    K Number: K844110 · Decision Nov 19, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    27

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    Basic Information

    Device Name
    XTRACETEZE SURGICAL SKIN STAPLE REMOVER 2001
    K Number
    K844110
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4760
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Pelco, Inc.
    Date Received
    October 23, 1984
    Decision Date
    November 19, 1984
    Product Code
    PYE
    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
    PYE Staple Removal Kit