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

    PISTON IRRIGATION TRAY

    K Number: K900737 · Decision Apr 19, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    14
    Applicant Total
    33
    Review Days
    62

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    Basic Information

    Device Name
    PISTON IRRIGATION TRAY
    K Number
    K900737
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Orion Life Systems, Inc.
    Date Received
    February 16, 1990
    Decision Date
    April 19, 1990
    Product Code
    EYN
    Advisory Committee
    Gastroenterology, Urology
    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
    EYN Tray, Irrigation, Sterile

    Similar 510(k) Clearances

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    Other Clearances by Orion Life Systems, Inc.

    K Number Device Name
    K943835 PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID
    K943834 STERILE .9% SODIUM CHLORIDE SOLUTION
    K943830 PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION
    K943836 PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER
    K943831 PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER
    K943832 STERILE .9% SODIUM CHLORIDE FOR IRRATION
    K943829 PRE-FILLED SYSRINGE W/STERILE WATER
    K943828 STERILE WATER FOR IRRIGATION
    K943833 STERILE WATER FOR IRRATION
    K923168 DUAL PORT ENTERAL Y-ADAPTOR
    Search all 33 clearances from Orion Life Systems, Inc. →