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

    PHOENIX EPIDURAL & SPINAL NEEDLES

    K Number: K990519 · Decision Jun 2, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    151
    Applicant Total
    12
    Review Days
    470

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    Basic Information

    Device Name
    PHOENIX EPIDURAL & SPINAL NEEDLES
    K Number
    K990519
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Myco Medical Supplies, Inc.
    Date Received
    February 18, 1999
    Decision Date
    June 2, 2000
    Product Code
    BSP
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

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    Other Clearances by Myco Medical Supplies, Inc.

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    K000592 UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET
    K982646 AILEE SUTURES AND AILEE NEEDLES
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    K963364 GLASS VAN GLASS SYRINGES
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