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

    CARRAKLENZ AND ULTRAKLENZ

    K Number: K022670 · Decision Oct 17, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    15
    Review Days
    66

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    Basic Information

    Device Name
    CARRAKLENZ AND ULTRAKLENZ
    K Number
    K022670
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Carrington Laboratories, Inc.
    Date Received
    August 12, 2002
    Decision Date
    October 17, 2002
    Product Code
    FRO
    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
    FRO Dressing, Wound, Drug

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    K961758 CARASYN HYDROGEL WOUND PRODUCTS
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    K951417 CARRASYN HYDROGEL WOUND DRESSING, FDG PADS, CARRAGAUZE PADS, STRIPS
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