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

    NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY

    K Number: K960584 · Decision Aug 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    117
    Applicant Total
    3
    Review Days
    185

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    Basic Information

    Device Name
    NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY
    K Number
    K960584
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Novavision, Inc.
    Date Received
    February 12, 1996
    Decision Date
    August 15, 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 Novavision, Inc.

    K Number Device Name
    K023623 NOVAVISION, MODEL 2.0
    K955900 NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR