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

    INTEC FULL FACE SHIELD

    K Number: K946003 · Decision Jun 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    801
    Registration Numbers
    801
    Same Product Code
    55
    Applicant Total
    2
    Review Days
    201

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    Basic Information

    Device Name
    INTEC FULL FACE SHIELD
    K Number
    K946003
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Intec Industries, Inc.
    Date Received
    December 9, 1994
    Decision Date
    June 28, 1995
    Product Code
    LYU
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LYU Accessory, Surgical Apparel

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