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

    MOBAY (BAYER) MERLON M-40 (H)F 1112

    K Number: K873822 · Decision Mar 24, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    81
    Applicant Total
    9
    Review Days
    185

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    Basic Information

    Device Name
    MOBAY (BAYER) MERLON M-40 (H)F 1112
    K Number
    K873822
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5928
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Applied Laboratories, Inc.
    Date Received
    September 21, 1987
    Decision Date
    March 24, 1988
    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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    K873825 GE LEXAN 144R 112
    K873823 MOBAY (BAYER) MAKROLON 2658 3291
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    K860677 EASY EYES TM LENS CARRYING CASE
    K853870 EASY EYES TM LENS CARRYING CASE