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

    CARRINGTON WOUND DRESSING 4X4(TM)

    K Number: K915001 · Decision Jan 31, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    15
    Review Days
    85

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    Basic Information

    Device Name
    CARRINGTON WOUND DRESSING 4X4(TM)
    K Number
    K915001
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Carrington Laboratories, Inc.
    Date Received
    November 7, 1991
    Decision Date
    January 31, 1992
    Product Code
    MGQ
    Advisory Committee
    Unknown
    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
    MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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