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

    GRIND NO MORE GENERATION II

    K Number: K094020 · Decision Jan 25, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    44
    Applicant Total
    8
    Review Days
    27

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    Basic Information

    Device Name
    GRIND NO MORE GENERATION II
    K Number
    K094020
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ranir, LLC
    Date Received
    December 29, 2009
    Decision Date
    January 25, 2010
    Product Code
    OBR
    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
    OBR Mouthguard, Over-The-Counter

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    Other Clearances by Ranir, LLC

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    K103004 SNORE GUARD
    K102118 SNORE GUARD ADVANCE
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    K063229 REST ASSURED NITE PROTECTOR