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

    STERILE SOFT TISSUE BIOPSY NEEDLE

    K Number: K854003 · Decision Oct 18, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    18

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    Basic Information

    Device Name
    STERILE SOFT TISSUE BIOPSY NEEDLE
    K Number
    K854003
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Co-Medical, Inc.
    Date Received
    September 30, 1985
    Decision Date
    October 18, 1985
    Product Code
    GEE
    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
    GEE Brush, Biopsy, General & Plastic Surgery

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    Other Clearances by Co-Medical, Inc.

    K Number Device Name
    K853623 CHIBA, MADAYAG, POTTS-COURNAND, SELDINGER BIOPSY N