BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇾 Malaysia

    SancDam Latex Oral Dam

    K Number: K212037 · Decision Mar 28, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    271

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    Basic Information

    Device Name
    SancDam Latex Oral Dam
    K Number
    K212037
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sanctuary Health Sdn. Bhd.
    Date Received
    June 30, 2021
    Decision Date
    March 28, 2022
    Product Code
    MSC
    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
    MSC Barrier, Std, Oral Sex

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