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

    SHELHIGH NO-REACT PNEUMOPLEDGETS

    K Number: K981756 · Decision Aug 5, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    335
    Applicant Total
    8
    Review Days
    79

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    Basic Information

    Device Name
    SHELHIGH NO-REACT PNEUMOPLEDGETS
    K Number
    K981756
    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 18, 1998
    Decision Date
    August 5, 1998
    Product Code
    FTL
    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
    FTL Mesh, Surgical, Polymeric

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    Other Clearances by Shelhigh, Inc.

    K Number Device Name
    K032893 SHELHIGH NO-REACT BIOCUFF
    K023940 SHELHIGH BIORING
    K982101 SHELHIGH NO-REACT DURA SHIELD
    K991567 SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.
    K982810 SHELHIGH NO-REACT VASCUPATCH
    K974914 SHELHIGH NO-REACT PERICARDIAL PATCHES
    K964467 SHELHIGH PERICARDIAL PATCH