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510(k) Data Aggregation

    K Number
    K991437
    Device Name
    WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00
    Manufacturer
    WELLS JOHNSON CO.
    Date Cleared
    1999-08-30

    (126 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    WELLS JOHNSON CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    General surgical fluid irrigation and infiltration.
    Device Description
    Not Found
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    K Number
    K984448
    Device Name
    BIRCOLL BALLOON DISSECTOR
    Manufacturer
    WELLS JOHNSON CO.
    Date Cleared
    1999-01-28

    (45 days)

    Product Code
    FZW, LCJ
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    WELLS JOHNSON CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BREAST RECONSTRUCTION, LIMB RECONSTRUCTION, CORRECTION OF CONGENITAL DEFORMITIES, COSMETIC DEFECTS, SCAR REVISION
    Device Description
    Not Found
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    K Number
    K971580
    Device Name
    UAS ULTRASONIC ASPIRATOR SYSTEM
    Manufacturer
    WELLS JOHNSON CO.
    Date Cleared
    1997-12-09

    (223 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    WELLS JOHNSON CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UAS is designed for use in the fragmentation, emilsification and aspiration of soft tissue in the following surgical specialties: Neurosurgery, Gastrointestinal and affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Gynecology, Orthopedic Surgery.
    Device Description
    Not Found
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