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

    TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC

    K Number: K990020 · Decision Jun 24, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    5
    Review Days
    171

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    Basic Information

    Device Name
    TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC
    K Number
    K990020
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Te ME NA S.A.R.L.
    Date Received
    January 4, 1999
    Decision Date
    June 24, 1999
    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 Te ME NA S.A.R.L.

    K Number Device Name
    K990323 TE ME NA POLYSTIM NERVE STIMILATOR
    K002405 SPINAL EPIDURAL NEEDLES
    K991259 TE ME NA EPIDURAL CATHETER
    K990100 POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE