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

    SPYROFLEX WOUND CLOSURES

    K Number: K921775 · Decision May 19, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    34
    Applicant Total
    5
    Review Days
    39

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    Basic Information

    Device Name
    SPYROFLEX WOUND CLOSURES
    K Number
    K921775
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5240
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Polymint Industrial Co. , Ltd.
    Date Received
    April 10, 1992
    Decision Date
    May 19, 1992
    Product Code
    FPX
    Advisory Committee
    General Hospital
    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
    FPX Strip, Adhesive, Closure, Skin

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    Other Clearances by Polymint Industrial Co. , Ltd.

    K Number Device Name
    K932457 SPYROGEL WOUND DRESSING
    K931634 VARIOUS KITS
    K911649 MITRASHEER TRANSPLANT DRESSING
    K891644 SAMBORD LATEX PATIENT EXAMINATION GLOVES