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

    SYRINGE, PISTON

    K Number: K821528 · Decision Jun 9, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    6
    Review Days
    19

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    Basic Information

    Device Name
    SYRINGE, PISTON
    K Number
    K821528
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Medcare Disp Products, Inc.
    Date Received
    May 21, 1982
    Decision Date
    June 9, 1982
    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 Medcare Disp Products, Inc.

    K Number Device Name
    K841949 DOSE RELEASE OF STERILIZATION LOTS
    K841405 INJECTION CAP OR ADAPTOR
    K840924 SYRINGE, PISTON, ARTERIAL BLOOD SAMPL
    K821529 DISPOSABLE HYPODERMIC NEEDLES
    K821530 SYRINGE IRRIGATING