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

    PAP-PAK CYTOBRUSH KIT

    K Number: K870398 · Decision Feb 25, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    72
    Applicant Total
    10
    Review Days
    23

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    Basic Information

    Device Name
    PAP-PAK CYTOBRUSH KIT
    K Number
    K870398
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Medical Packaging Corp.
    Date Received
    February 2, 1987
    Decision Date
    February 25, 1987
    Product Code
    HHT
    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
    HHT Spatula, Cervical, Cytological

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    Other Clearances by Medical Packaging Corp.

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    K964637 CULTURE COLLECTION AND TRANSPORT SYSTEM, MODIFIED AMIES MEDIA
    K936078 CULTURE-PAK COLLECTION/TRANSPORT SYSTEM, MODIFIED
    K932337 CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM
    K915454 CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
    K881105 CULTURE COLLECTION DEVICE
    K864323 CYTOLOGY BRUSHES