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

    ACU-SYRINGE W/WO NEEDLES

    K Number: K854877 · Decision Feb 19, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    13
    Review Days
    75

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    Basic Information

    Device Name
    ACU-SYRINGE W/WO NEEDLES
    K Number
    K854877
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Acuderm, Inc.
    Date Received
    December 6, 1985
    Decision Date
    February 19, 1986
    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 Acuderm, Inc.

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    K915000 ACU-GUARD
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    K832582 MYCOSEL AGAR
    K832583 SABOURAUD DEXTROSE AGAR
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