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

    P.A. ENTERAL FEEDING BAG 1100

    K Number: K853309 · Decision Aug 27, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    5
    Review Days
    20

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    Basic Information

    Device Name
    P.A. ENTERAL FEEDING BAG 1100
    K Number
    K853309
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Pa Medical Corp.
    Date Received
    August 7, 1985
    Decision Date
    August 27, 1985
    Product Code
    KNT
    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
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by Pa Medical Corp.

    K Number Device Name
    K910903 INFLATE-A-CUFF #7014
    K871449 ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG
    K860084 PRESSURE INFUSOR #1900
    K854595 P.A. MEDICAL VAGINAL IRRIGATION SET #1130