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

    SNORE-CURE ANTI-SNORING APPLIANCE

    K Number: K980952 · Decision Jun 1, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    105
    Registration Numbers
    105
    Same Product Code
    212
    Applicant Total
    2
    Review Days
    80

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    Basic Information

    Device Name
    SNORE-CURE ANTI-SNORING APPLIANCE
    K Number
    K980952
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ORTHO-TAIN, Inc.
    Date Received
    March 13, 1998
    Decision Date
    June 1, 1998
    Product Code
    LRK
    Advisory Committee
    Dental
    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
    LRK Device, Anti-Snoring

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