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

    MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE

    K Number: K940088 · Decision Aug 4, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    8
    Review Days
    209

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    Basic Information

    Device Name
    MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE
    K Number
    K940088
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Technical Products
    Date Received
    January 7, 1994
    Decision Date
    August 4, 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 Medical Technical Products

    K Number Device Name
    K940083 STANDARD PHACO TIP 15, 30, 45, 60
    K940084 MODEL 2000 OPHTHALMIC SURGICAL SYSTEM
    K910335 MTP TRANSPORT INFUSION PUMP, MODEL NO. MTPLEA
    K905251 MTP TRANSPORT INFUSION PUMP MODEL NO. 1001A
    K904612 I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)
    K871474 PART #860070 ULTRAPAK & #860075 ULTRAPAK
    K871473 PART #860065 IA PAK & PART #860060 IA PAK