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

    ELASTO-GEL MANUKA HONEY WOUND DRESSING

    K Number: K083334 · Decision Jul 30, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    5
    Review Days
    260

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    Basic Information

    Device Name
    ELASTO-GEL MANUKA HONEY WOUND DRESSING
    K Number
    K083334
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Southwest Technologies, Inc.
    Date Received
    November 12, 2008
    Decision Date
    July 30, 2009
    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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    Other Clearances by Southwest Technologies, Inc.

    K Number Device Name
    K102478 OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING
    K030774 STIMULEN COLLAGEN
    K872488 ELASTO-GEL CAST & SPLINT PADS
    K872165 ELASTO-GEL OCCLUSIVE DRESSING