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

    HAND-HELD IRRIGATION PUMP

    K Number: K933757 · Decision Aug 26, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    11
    Review Days
    408

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    Basic Information

    Device Name
    HAND-HELD IRRIGATION PUMP
    K Number
    K933757
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ximed Medical Systems
    Date Received
    July 14, 1993
    Decision Date
    August 26, 1994
    Product Code
    BTA
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTA Pump, Portable, Aspiration (Manual Or Powered)

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    Other Clearances by Ximed Medical Systems

    K Number Device Name
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    K933458 SURGICAL TROCARS
    K922714 UNIVERSAL IRRIGATION & SUCTION TUBING SET
    K922523 BIPOLAR ELECTROSURGICAL PROBES & INSTRUMENTS
    K903812 ELECTROPROBE SINGLE-USE SURGICAL PROBE
    K900463 LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS
    K892933 INFRALASE-LASERGUIDE DELIVERY SYSTEM
    K890775 INFRALASE - LASERGUIDE DELIVERY SYSTEM
    K891126 MICROLASE CO2 LASER MICROMANIPULATOR
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