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

    INJECT-EASE

    K Number: K872233 · Decision Sep 4, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    46
    Applicant Total
    9
    Review Days
    86

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    Basic Information

    Device Name
    INJECT-EASE
    K Number
    K872233
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6920
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Palco Laboratories, Inc.
    Date Received
    June 10, 1987
    Decision Date
    September 4, 1987
    Product Code
    KZH
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KZH Introducer, Syringe Needle

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    K913694 PALCO LABS LOADMATIC
    K911191 PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR
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    K842547 WET-STOP
    K833344 AUTO-LANCET