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

    STRYKER DROP APPLICATOR, KITS, SPRAY APPLICATOR KIT, TIPS

    K Number: K950824 · Decision Aug 25, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    124
    Review Days
    183

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    Basic Information

    Device Name
    STRYKER DROP APPLICATOR, KITS, SPRAY APPLICATOR KIT, TIPS
    K Number
    K950824
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Corp.
    Date Received
    February 23, 1995
    Decision Date
    August 25, 1995
    Product Code
    FMF
    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
    FMF Syringe, Piston

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