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

    BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE

    K Number: K964597 · Decision Sep 8, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    4
    Review Days
    294

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    Basic Information

    Device Name
    BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE
    K Number
    K964597
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biosurgical Corp.
    Date Received
    November 18, 1996
    Decision Date
    September 8, 1997
    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 Biosurgical Corp.

    K Number Device Name
    K000438 MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER
    K000048 SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1
    K992351 SEALOUETTE FIBRIN SEALANT APPLICATOR