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

    GENT-L-KARE LACERATION TRAYS

    K Number: K950850 · Decision Mar 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    9
    Review Days
    18

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    Basic Information

    Device Name
    GENT-L-KARE LACERATION TRAYS
    K Number
    K950850
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Premium Plastics, Inc.
    Date Received
    February 24, 1995
    Decision Date
    March 14, 1995
    Product Code
    FRG
    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
    FRG Wrap, Sterilization

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