BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PINT BOTTLE WELL

    K Number: K781364 · Decision Oct 17, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    276
    Same Product Code
    10
    Applicant Total
    16
    Review Days
    71

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    Basic Information

    Device Name
    PINT BOTTLE WELL
    K Number
    K781364
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6430
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Baxa Corp., Sub. of Cook Group, Inc.
    Date Received
    August 7, 1978
    Decision Date
    October 17, 1978
    Product Code
    KYX
    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
    KYX Dispenser, Liquid Medication

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    K844904 CYTOSAFE NEEDLE
    K832332 VENTED I.V. TRANSFER NEEDLE
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