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

    IRRIGATION SET W/PISTON SYRINGE

    K Number: K803198 · Decision Jan 15, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    11
    Review Days
    29

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    Basic Information

    Device Name
    IRRIGATION SET W/PISTON SYRINGE
    K Number
    K803198
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Walpak Co.
    Date Received
    December 17, 1980
    Decision Date
    January 15, 1981
    Product Code
    FMF
    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
    FMF Syringe, Piston

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    Other Clearances by Walpak Co.

    K Number Device Name
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    K803201 LEMON GLYCERINE SWABS
    K802083 CATHETER INSERTION TRAY
    K791598 CLOSED SYSTEM FOLEY CATHERIZATION PROCED
    K780123 CATHETERIZATION PROCEDURE TRAY
    K780124 CATHETERIZATION PROCED. TRAY, URETHRAL
    K770446 SPONGES, LAPAROTOMY
    K760560 CATH CARE KIT
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