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

    STOPPERLESS HOT/COLD RUBBER WATER BOTTLE

    K Number: K810654 · Decision Mar 27, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    111
    Applicant Total
    6
    Review Days
    17

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    Basic Information

    Device Name
    STOPPERLESS HOT/COLD RUBBER WATER BOTTLE
    K Number
    K810654
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    First Industries, Inc.
    Date Received
    March 10, 1981
    Decision Date
    March 27, 1981
    Product Code
    FDF
    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
    FDF Colonoscope And Accessories, Flexible/Rigid

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    Other Clearances by First Industries, Inc.

    K Number Device Name
    K810651 ORAL AIRWAYS
    K810652 TUBING CONNECTORS
    K810653 VINYL ICE BAG
    K810649 INVALID CUSHION
    K810650 CRUTCH TIPS & GRIPS