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

    CUSTOM ORTHOPAEDIC TRAYS (PACKS)

    K Number: K930507 · Decision Feb 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    8
    Applicant Total
    29
    Review Days
    386

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    Basic Information

    Device Name
    CUSTOM ORTHOPAEDIC TRAYS (PACKS)
    K Number
    K930507
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.4540
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Associated Medical Products Co.
    Date Received
    February 1, 1993
    Decision Date
    February 22, 1994
    Product Code
    HTS
    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
    HTS Knife, Orthopedic

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