BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ASCON SURGICAL INSTRUMENTS

    K Number: K852057 · Decision Jun 27, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    276
    Same Product Code
    43
    Applicant Total
    6
    Review Days
    49

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    Basic Information

    Device Name
    ASCON SURGICAL INSTRUMENTS
    K Number
    K852057
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Ascon Medical Instruments, Ltd.
    Date Received
    May 9, 1985
    Decision Date
    June 27, 1985
    Product Code
    HNR
    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
    HNR Forceps, Ophthalmic

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    Other Clearances by Ascon Medical Instruments, Ltd.

    K Number Device Name
    K852054 CONTACT LENS LOUPE, INSPETION LOUPE
    K852055 ASCON OPHTHALMIC SPONGE
    K852548 ATL 225 MW TRAIL LENS SET
    K852056 ACC CROSS CYLINDERS
    K852126 ATF 101 TRAIL FRAME