BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇿 Czechia

    Dilapan-S

    K Number: K143447 · Decision Apr 17, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    136

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    Basic Information

    Device Name
    Dilapan-S
    K Number
    K143447
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4260
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medicem Technology S.R.O
    Date Received
    December 2, 2014
    Decision Date
    April 17, 2015
    Product Code
    PKN
    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
    PKN Dilator, Cervical, Synthetic, Osmotic