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

    MANAN EPIDURAL NEEDLE

    K Number: K852428 · Decision Jun 27, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    78
    Same Product Code
    7
    Applicant Total
    20
    Review Days
    20

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    Basic Information

    Device Name
    MANAN EPIDURAL NEEDLE
    K Number
    K852428
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Manan Manufacturing Co., Inc.
    Date Received
    June 7, 1985
    Decision Date
    June 27, 1985
    Product Code
    GCB
    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
    GCB Needle, Catheter

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    Other Clearances by Manan Manufacturing Co., Inc.

    K Number Device Name
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    K852501 MYELOGRAM PROCEDURE TRAY
    K851832 NAMAN POTTS COURNAND NEEDLE
    K851834 MANAN GWI GUIDE WIRE INTRODUCER
    K851833 MANAN SELDINGER NEEDLE
    K852018 ARTHROGRAM TRAY FOR DOUBLE & SINGLE CONTRAST ARTHR
    K852426 MANAN TROCAR STYLE BIOPSY NEEDLE
    K852427 MANAN SPINAL NEEDLE
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