BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NON-STERILE SUTURE NEEDLES

    K Number: K881394 · Decision Apr 8, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    4

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    Basic Information

    Device Name
    NON-STERILE SUTURE NEEDLES
    K Number
    K881394
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    China National Medicines C/O Havel'S
    Date Received
    April 4, 1988
    Decision Date
    April 8, 1988
    Product Code
    GDL
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GDL Needle, Suturing, Reusable

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