BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080

    K Number: K000544 · Decision Mar 9, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    0
    Applicant Total
    3
    Review Days
    20

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    Basic Information

    Device Name
    BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080
    K Number
    K000544
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.5810
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Labtician Ophthalmics, Inc.
    Date Received
    February 18, 2000
    Decision Date
    March 9, 2000
    Product Code
    HJX
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HJX Reader, Prism, Ophthalmic

    Other Clearances by Labtician Ophthalmics, Inc.

    K Number Device Name
    K990224 LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET
    K983607 LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS