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

    DISPOSABLE SYRINGE WITH NEEDLE

    K Number: K870191 · Decision Apr 16, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    6
    Review Days
    86

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    Basic Information

    Device Name
    DISPOSABLE SYRINGE WITH NEEDLE
    K Number
    K870191
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Can-Am Surgical Corp.
    Date Received
    January 20, 1987
    Decision Date
    April 16, 1987
    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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    Other Clearances by Can-Am Surgical Corp.

    K Number Device Name
    K870190 DISPOSABLE SYRINGE W/O NEEDLE
    K870192 DISPOSABLE SYRINGE TUBERCULIN W/NEEDLE
    K870193 A+MED DISPOSABLE NEEDLE
    K870018 E-Z JECT INSULIN SYRINGE
    K870017 AMG + MED LANCET