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

    SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.

    K Number: K991567 · Decision Jul 14, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    162
    Applicant Total
    8
    Review Days
    70

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    Basic Information

    Device Name
    SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.
    K Number
    K991567
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shelhigh, Inc.
    Date Received
    May 5, 1999
    Decision Date
    July 14, 1999
    Product Code
    FTM
    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
    FTM Mesh, Surgical

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    Other Clearances by Shelhigh, Inc.

    K Number Device Name
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    K982101 SHELHIGH NO-REACT DURA SHIELD
    K982810 SHELHIGH NO-REACT VASCUPATCH
    K981756 SHELHIGH NO-REACT PNEUMOPLEDGETS
    K974914 SHELHIGH NO-REACT PERICARDIAL PATCHES
    K964467 SHELHIGH PERICARDIAL PATCH