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

    ROWE SHOULDER INSTR. FOR BANKHART REPAIR

    K Number: K820344 · Decision Mar 8, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    658
    Registration Numbers
    658
    Same Product Code
    72
    Applicant Total
    18
    Review Days
    28

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    Basic Information

    Device Name
    ROWE SHOULDER INSTR. FOR BANKHART REPAIR
    K Number
    K820344
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    New England Surgical Instrument Corp.
    Date Received
    February 8, 1982
    Decision Date
    March 8, 1982
    Product Code
    HTD
    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
    HTD Forceps

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    Other Clearances by New England Surgical Instrument Corp.

    K Number Device Name
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    K883396 HANDSWITCHING MONOPOLAR PENCIL
    K880863 BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200
    K880859 SURGICAL BURS
    K872271 VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS
    K872209 ARTHROPLASTY MALLET
    K864770 SUCTION TUBE
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