BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇰🇷 South Korea

    OraCure

    K Number: K183436 · Decision Sep 18, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    40
    Applicant Total
    2
    Review Days
    281

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    Basic Information

    Device Name
    OraCure
    K Number
    K183436
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tbm Corporation
    Date Received
    December 11, 2018
    Decision Date
    September 18, 2019
    Product Code
    OLR
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OLR Oral Wound Dressing

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    Other Clearances by Tbm Corporation

    K Number Device Name
    K211851 Ora-Aid