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

    NORMAL SALINE FLUSH SYRINGE

    K Number: K984614 · Decision May 27, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    3
    Review Days
    149

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    Basic Information

    Device Name
    NORMAL SALINE FLUSH SYRINGE
    K Number
    K984614
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rocap Div. of Sabratek Corp.
    Date Received
    December 29, 1998
    Decision Date
    May 27, 1999
    Product Code
    FOZ
    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
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Rocap Div. of Sabratek Corp.

    K Number Device Name
    K990308 ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML
    K990390 HEPARIN IV FLUSH SYRINGE, 10 U/ML \