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

    STAND, OPERATING ROOM

    K Number: K852329 · Decision Jun 14, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    278
    Registration Numbers
    278
    Same Product Code
    35
    Applicant Total
    8
    Review Days
    14

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    Basic Information

    Device Name
    STAND, OPERATING ROOM
    K Number
    K852329
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6990
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Scholten Surgical Instruments, Inc.
    Date Received
    May 31, 1985
    Decision Date
    June 14, 1985
    Product Code
    FOX
    Advisory Committee
    General Hospital
    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
    FOX Stand, Infusion

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    Other Clearances by Scholten Surgical Instruments, Inc.

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    K852119 TEMPORARY PACEMAKER GROUND WIRE
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    K852330 RETRACTOR, SURGICAL