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

    SPIRIT RIDGE SILICONE CARVING BLOCK

    K Number: K952706 · Decision Aug 28, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    41
    Applicant Total
    5
    Review Days
    75

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    Basic Information

    Device Name
    SPIRIT RIDGE SILICONE CARVING BLOCK
    K Number
    K952706
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3680
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Spirit Ridge Technologies
    Date Received
    June 14, 1995
    Decision Date
    August 28, 1995
    Product Code
    FZE
    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
    FZE Prosthesis, Nose, Internal

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    Other Clearances by Spirit Ridge Technologies

    K Number Device Name
    K952707 SILICONE ELASTOMER MALAR IMPLANT
    K952709 PROTHESIS, CHIN, INTERNAL
    K952708 PECTORALIS IMPLANT
    K952705 SPIRIT RIDGE NASAL IMPLANT