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

    QS DELIVERY SYSTEM

    K Number: K991254 · Decision Aug 23, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    368
    Registration Numbers
    368
    Same Product Code
    40
    Applicant Total
    2
    Review Days
    132

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    Basic Information

    Device Name
    QS DELIVERY SYSTEM
    K Number
    K991254
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6960
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sub-Q, Inc.
    Date Received
    April 13, 1999
    Decision Date
    August 23, 1999
    Product Code
    KYZ
    Advisory Committee
    General Hospital
    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
    KYZ Syringe, Irrigating (Non Dental)

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