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

    SLIP-ON FIXATION SPLINT (SFS)

    K Number: K934468 · Decision Aug 5, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    329

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    Basic Information

    Device Name
    SLIP-ON FIXATION SPLINT (SFS)
    K Number
    K934468
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3165
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gatewood Splints
    Date Received
    September 10, 1993
    Decision Date
    August 5, 1994
    Product Code
    EHO
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EHO Bar, Preformed

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