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

    DISPOSABLE ACCESSORIES FOR I/A SYS. & VITEOUS CUT.

    K Number: K860957 · Decision Jun 2, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    4
    Review Days
    81

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    Basic Information

    Device Name
    DISPOSABLE ACCESSORIES FOR I/A SYS. & VITEOUS CUT.
    K Number
    K860957
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Medical Corp. of America
    Date Received
    March 13, 1986
    Decision Date
    June 2, 1986
    Product Code
    HQC
    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
    HQC Unit, Phacofragmentation

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    Other Clearances by Medical Corp. of America

    K Number Device Name
    K860956 KANSAS I/A SYSTEM & KANSAS I/A & VITRECTROMY SYST.
    K854116 PHACO PACKS, 1A PACKS & PACK COMPONENTS
    K853883 TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR