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

    AMG + MED LANCET

    K Number: K870017 · Decision Jan 21, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    157
    Registration Numbers
    157
    Same Product Code
    109
    Applicant Total
    6
    Review Days
    19

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    Basic Information

    Device Name
    AMG + MED LANCET
    K Number
    K870017
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4850
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Can-Am Surgical Corp.
    Date Received
    January 2, 1987
    Decision Date
    January 21, 1987
    Product Code
    FMK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

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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
    K870191 DISPOSABLE SYRINGE WITH NEEDLE
    K870193 A+MED DISPOSABLE NEEDLE
    K870018 E-Z JECT INSULIN SYRINGE