BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE

    K Number: K910252 · Decision Mar 4, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    8
    Applicant Total
    41
    Review Days
    41

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    Basic Information

    Device Name
    POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE
    K Number
    K910252
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5100
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    CooperSurgical, Inc.
    Date Received
    January 22, 1991
    Decision Date
    March 4, 1991
    Product Code
    HEE
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HEE Set, Anesthesia, Paracervical

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