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

    SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK

    K Number: K935391 · Decision Feb 24, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    299
    Registration Numbers
    299
    Same Product Code
    26
    Applicant Total
    76
    Review Days
    108

    Basic Information

    Device Name
    SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK
    K Number
    K935391
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3M HEALTH CARE, SARNS
    Date Received
    November 8, 1993
    Decision Date
    February 24, 1994
    Product Code
    GFA
    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
    GFA Blade, Saw, General & Plastic Surgery, Surgical

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