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

    HYLASINE

    K Number: K993362 · Decision Mar 13, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    60
    Same Product Code
    46
    Applicant Total
    2
    Review Days
    159

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    Basic Information

    Device Name
    HYLASINE
    K Number
    K993362
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4100
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomatrix, Inc.
    Date Received
    October 6, 1999
    Decision Date
    March 13, 2000
    Product Code
    EMX
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EMX Balloon, Epistaxis

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    Other Clearances by Biomatrix, Inc.

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    K994170 HYLASHIELD CL