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

    STERILE .9% SODIUM CHLORIDE FOR IRRATION

    K Number: K943832 · Decision Nov 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    331
    Registration Numbers
    331
    Same Product Code
    83
    Applicant Total
    33
    Review Days
    108

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    Basic Information

    Device Name
    STERILE .9% SODIUM CHLORIDE FOR IRRATION
    K Number
    K943832
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Orion Life Systems, Inc.
    Date Received
    August 5, 1994
    Decision Date
    November 21, 1994
    Product Code
    JOL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOL Catheter And Tip, Suction

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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
    K943829 PRE-FILLED SYSRINGE W/STERILE WATER
    K943828 STERILE WATER FOR IRRIGATION
    K943833 STERILE WATER FOR IRRATION
    K923168 DUAL PORT ENTERAL Y-ADAPTOR
    K923497 FLUSHING IRRIGATION SET
    Search all 33 clearances from Orion Life Systems, Inc. →