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

    NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE

    K Number: K915530 · Decision Aug 17, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    19
    Applicant Total
    20
    Review Days
    251

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    Basic Information

    Device Name
    NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE
    K Number
    K915530
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5960
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Threshold Industries, Inc.
    Date Received
    December 10, 1991
    Decision Date
    August 17, 1992
    Product Code
    HAX
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HAX Tong, Skull For Traction

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