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

    PERITONEAL PAC

    K Number: K791426 · Decision Aug 28, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    112
    Applicant Total
    16
    Review Days
    33

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    Basic Information

    Device Name
    PERITONEAL PAC
    K Number
    K791426
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Intermed, Inc.
    Date Received
    July 26, 1979
    Decision Date
    August 28, 1979
    Product Code
    KDJ
    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
    KDJ Set, Administration, For Peritoneal Dialysis, Disposable

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    Other Clearances by Intermed, Inc.

    K Number Device Name
    K900857 NON STERILE PARENTERAL SUPPLY KIT
    K842166 INTERMED, INS STERILE WATER/SALINE
    K833126 DRESSING CHANGE TRAYS
    K833574 PERCUTANEOUS SHEATH INTRODUCER TRAYS
    K833573 CENTRAL VEIN CATH. TRAY CC-20-1420
    K833139 ACUTE HEMODIALYSIS TRAYS
    K833059 SUCTION CATHETER TRAYS
    K821269 TRACHEOSTOMY CARE TRAYS
    K791427 CATHETERIZATION TRAYS FOLEY AND URETHRAL
    K781748 IRRIGATION TRAY
    Search all 16 clearances from Intermed, Inc. →