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

    PHACO NEEDLES AND TIPS

    K Number: K943672 · Decision Oct 13, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    9
    Review Days
    79

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    Basic Information

    Device Name
    PHACO NEEDLES AND TIPS
    K Number
    K943672
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Microsurgical Technology, Inc.
    Date Received
    July 26, 1994
    Decision Date
    October 13, 1994
    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 Microsurgical Technology, Inc.

    K Number Device Name
    K953959 PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES
    K946194 WEE BAG O'MERCURY
    K942403 INFUSION CANNULA
    K934844 INTER TIP T
    K854402 THE NEW MCINTYRE I.A. HANDPIECE
    K854401 THE NEW MOBILE TIP MCINTYRE CANNULA
    K853777 THE NEW MCINTYRE CANNULA
    K840442 STERILIZED DISPOS. CYSTOTOME