BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇵🇱 Poland

    DropSafe Safety Pen Needles

    K Number: K211716 · Decision Jan 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    1
    Review Days
    218

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    Basic Information

    Device Name
    DropSafe Safety Pen Needles
    K Number
    K211716
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Htl Strefa SA
    Date Received
    June 3, 2021
    Decision Date
    January 7, 2022
    Product Code
    FMI
    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
    FMI Needle, Hypodermic, Single Lumen

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