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

    TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS

    K Number: K955366 · Decision Mar 28, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    117
    Applicant Total
    10
    Review Days
    127

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    Basic Information

    Device Name
    TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS
    K Number
    K955366
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rand Scientific Corp.
    Date Received
    November 22, 1995
    Decision Date
    March 28, 1996
    Product Code
    HQD
    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
    HQD Lens, Contact (Other Material) - Daily

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    Other Clearances by Rand Scientific Corp.

    K Number Device Name
    K963856 RAND NASAL PACKING
    K961081 SPIRIT RIDGE SILICONE CARVING BLOCK
    K961057 DURALASTIC SHEETING II
    K955777 PMMA CLASIC
    K961124 THE NAUTILUS
    K961071 THE MAGNUM CHIN IMPLANT
    K961080 MEDIAL MALAR IMPLANT
    K961072 PEC IMPLANT
    K952165 TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS