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

    SURGICAL BURS

    K Number: K880859 · Decision Mar 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    15
    Applicant Total
    18
    Review Days
    20

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    Basic Information

    Device Name
    SURGICAL BURS
    K Number
    K880859
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    New England Surgical Instrument Corp.
    Date Received
    March 1, 1988
    Decision Date
    March 21, 1988
    Product Code
    GFF
    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
    GFF Bur, Surgical, General & Plastic Surgery

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    Other Clearances by New England Surgical Instrument Corp.

    K Number Device Name
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    K895331 ELECTROSURGICAL ELECTRODE
    K883963 RANEY AND LEROY-RANEY SCALP CLIP
    K883396 HANDSWITCHING MONOPOLAR PENCIL
    K880863 BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200
    K872271 VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS
    K872209 ARTHROPLASTY MALLET
    K864770 SUCTION TUBE
    K864775 CHISEL (OSTEOTOME, GOUGE, ETC.)
    K864771 CHUCK HANDLE
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