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

    NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO

    K Number: K092908 · Decision Mar 10, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    13
    Review Days
    169

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    Basic Information

    Device Name
    NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO
    K Number
    K092908
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neomed, Inc.
    Date Received
    September 22, 2009
    Decision Date
    March 10, 2010
    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 Neomed, Inc.

    K Number Device Name
    K183540 Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)
    K161039 NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)
    K152857 NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps
    K143344 NeoMed NeoConnect Enteral Syringes with ENFit Connector
    K122373 NEOMED ORAL/ENTERAL SYRINGE
    K120182 NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES
    K100288 NEOMED ENTERAL ONLY EXTENSION SET
    K082238 NEOMED POLYURETHANE FEEDING TUBE
    K081515 NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0
    K073596 NEOMED SINGLE LUMEN UMBILICAL CATHETER
    Search all 13 clearances from Neomed, Inc. →