BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AquaFlate Pre-Filled Sterile Water Syringe 10mL

    K Number: K200556 · Decision Mar 31, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    119
    Registration Numbers
    119
    Same Product Code
    127
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    AquaFlate Pre-Filled Sterile Water Syringe 10mL
    K Number
    K200556
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    H R Pharmaceuticals, Inc.
    Date Received
    March 3, 2020
    Decision Date
    March 31, 2020
    Product Code
    EZL
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    EZL Catheter, Retention Type, Balloon

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    Other Clearances by H R Pharmaceuticals, Inc.

    K Number Device Name
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