BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    RETRACTOR

    K Number: K954508 · Decision Nov 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    49
    Review Days
    47

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    Basic Information

    Device Name
    RETRACTOR
    K Number
    K954508
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phx Technologies Corp.
    Date Received
    September 28, 1995
    Decision Date
    November 14, 1995
    Product Code
    HRX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HRX Arthroscope

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    Other Clearances by Phx Technologies Corp.

    K Number Device Name
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    K954459 CONICAL OBTURATOR
    K954475 BLUNT DISSECTOR, CURVED
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    K954458 BOAT NOSE OBTURATOR
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