BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    ASIK 'ONCE' SYRINGE

    K Number: K852444 · Decision Oct 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    9
    Review Days
    128

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    Basic Information

    Device Name
    ASIK 'ONCE' SYRINGE
    K Number
    K852444
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Pharma-Plast USA, Inc.
    Date Received
    June 10, 1985
    Decision Date
    October 16, 1985
    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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    K884978 PHARMA-PLAST INSULIN INFUSION SET
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