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

    J & J DIP WATER ADDITIVE

    K Number: K821693 · Decision Jul 2, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    7
    Applicant Total
    206
    Review Days
    24

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    Basic Information

    Device Name
    J & J DIP WATER ADDITIVE
    K Number
    K821693
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.3910
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Johnson & Johnson Professionals, Inc.
    Date Received
    June 8, 1982
    Decision Date
    July 2, 1982
    Product Code
    FYH
    Advisory Committee
    General, Plastic Surgery
    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
    FYH Splint, Extremity, Noninflatable, External, Sterile

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