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

    HUFFMAN BIOPSY UNIT

    K Number: K873176 · Decision Oct 14, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    188
    Registration Numbers
    188
    Same Product Code
    38
    Applicant Total
    8
    Review Days
    63

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    Basic Information

    Device Name
    HUFFMAN BIOPSY UNIT
    K Number
    K873176
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Penn Medical Devices, Inc.
    Date Received
    August 12, 1987
    Decision Date
    October 14, 1987
    Product Code
    FCL
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FCL Forceps, Biopsy, Non-Electric

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