BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇷 Greece

    WATER IRRIGATOR, W1 200

    K Number: K941325 · Decision Aug 9, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    144

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    Basic Information

    Device Name
    WATER IRRIGATOR, W1 200
    K Number
    K941325
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.1800
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Strong Medical, Inc.
    Date Received
    March 18, 1994
    Decision Date
    August 9, 1994
    Product Code
    KHH
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KHH Stimulator, Caloric-Air

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