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

    ARTHRO-PREP REST

    K Number: K812396 · Decision Nov 20, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    92

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ARTHRO-PREP REST
    K Number
    K812396
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4950
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Northwest Surgical Concepts, Inc.
    Date Received
    August 20, 1981
    Decision Date
    November 20, 1981
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (BWN), ordered by most recent decision date.

    AIRFRAME SURGICAL DRAPE SUPPORT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    INFINITECH BREATH EZ

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ISI SELF-SUPPORTING ARM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    HOLDER, PEDIATRIC POSITION

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BAUMER SURGICAL TABLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Northwest Surgical Concepts, Inc.

    K Number Device Name
    K812395 ARTHRO-PREP REST W/STAND