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

    TABLE ACCESSORIES, OPERATING ROOM

    K Number: K852332 · Decision Jul 2, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    19
    Applicant Total
    8
    Review Days
    32

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    Basic Information

    Device Name
    TABLE ACCESSORIES, OPERATING ROOM
    K Number
    K852332
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4950
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Scholten Surgical Instruments, Inc.
    Date Received
    May 31, 1985
    Decision Date
    July 2, 1985
    Product Code
    BWN
    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
    BWN Table And Attachments, Operating-Room

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    Other Clearances by Scholten Surgical Instruments, Inc.

    K Number Device Name
    K072051 NOVATOME, MODEL: SU101-50
    K900405 SCHOLTEN FRAME
    K852331 SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC
    K852119 TEMPORARY PACEMAKER GROUND WIRE
    K852120 FORCEPS, BIOPSY(NON RIGID)
    K852330 RETRACTOR, SURGICAL
    K852329 STAND, OPERATING ROOM