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

    COMFEES(R) + CON-PAK(TM) LENS CASE

    K Number: K897085 · Decision Feb 28, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    81
    Applicant Total
    8
    Review Days
    70

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    Basic Information

    Device Name
    COMFEES(R) + CON-PAK(TM) LENS CASE
    K Number
    K897085
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Magnivision, Inc.
    Date Received
    December 20, 1989
    Decision Date
    February 28, 1990
    Product Code
    LRX
    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
    LRX Case, Contact Lens

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    Other Clearances by Magnivision, Inc.

    K Number Device Name
    K900777 ITEM #273 CONTACT LENS CASES
    K900778 ITEM #272 MAGNIF-EYES CONTACT LENS CASE
    K897084 CONFEES(R)+ CONTACT LENS HOLDER
    K882384 DELUXE CONTACT LENS HOLDER (HARD & SOFT) #283
    K890533 ITEM #352/#CS352* CONTACT LENS CASES
    K872567 SOFT CONTACT LENS REMOVER
    K872591 HARD CONTACT LENS REMOVER. ITEM #289