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

    TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR

    K Number: K853883 · Decision Oct 8, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    4
    Review Days
    19

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    Basic Information

    Device Name
    TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR
    K Number
    K853883
    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
    September 19, 1985
    Decision Date
    October 8, 1985
    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
    K860957 DISPOSABLE ACCESSORIES FOR I/A SYS. & VITEOUS CUT.
    K860956 KANSAS I/A SYSTEM & KANSAS I/A & VITRECTROMY SYST.
    K854116 PHACO PACKS, 1A PACKS & PACK COMPONENTS