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

    PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID

    K Number: K943835 · Decision Jan 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    63
    Applicant Total
    33
    Review Days
    172

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    Basic Information

    Device Name
    PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID
    K Number
    K943835
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Orion Life Systems, Inc.
    Date Received
    August 5, 1994
    Decision Date
    January 24, 1995
    Product Code
    KNY
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNY Accessories, Catheter, G-U

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    Other Clearances by Orion Life Systems, Inc.

    K Number Device Name
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    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
    K923497 FLUSHING IRRIGATION SET
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