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

    DEY-PAK PURIFIED WATER, USP, STERILE

    K Number: K875011 · Decision Jan 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    61
    Applicant Total
    6
    Review Days
    49

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    Basic Information

    Device Name
    DEY-PAK PURIFIED WATER, USP, STERILE
    K Number
    K875011
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5640
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Dey Laboratories, Inc.
    Date Received
    December 4, 1987
    Decision Date
    January 22, 1988
    Product Code
    CCQ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CCQ Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

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