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

    AQUA SPRAY

    K Number: K971941 · Decision Aug 14, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    40
    Applicant Total
    2
    Review Days
    79

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    Basic Information

    Device Name
    AQUA SPRAY
    K Number
    K971941
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boyd Industries, Inc.
    Date Received
    May 27, 1997
    Decision Date
    August 14, 1997
    Product Code
    GEY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GEY Motor, Surgical Instrument, Ac-Powered

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