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

    COVER, ARMBOARD, DISPOSABLE

    K Number: K770391 · Decision Mar 7, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    12
    Applicant Total
    5
    Review Days
    7

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    Basic Information

    Device Name
    COVER, ARMBOARD, DISPOSABLE
    K Number
    K770391
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.3910
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Precept, Inc.
    Date Received
    February 28, 1977
    Decision Date
    March 7, 1977
    Product Code
    BTX
    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
    BTX Board, Arm (With Cover), Sterile

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    Other Clearances by Precept, Inc.

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    K760360 SHIRT, MITTEN CUFF INFANT