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510(k) Data Aggregation

    K Number
    K951728
    Device Name
    SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE
    Manufacturer
    MIRA, INC.
    Date Cleared
    1997-03-19

    (706 days)

    Product Code
    HLI
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIRA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K950806
    Device Name
    SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS
    Manufacturer
    MIRA, INC.
    Date Cleared
    1996-06-05

    (469 days)

    Product Code
    HQX
    Regulation Number
    886.3340
    Why did this record match?
    Applicant Name (Manufacturer) :

    MIRA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the modified Solid Silicone and Silicone Sponge Implants is unchanged from the pre-amendment and cleared MIRA Solid Silicone and Silicone Sponge Implants. These devices are used to "buckle" the sclera in retinal reattachment surgery.
    Device Description
    Solid Silicone and Silicone Sponge Implants are molded extruded silicone devices, available in a wide variety of shapes and sizes.
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