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

    ELTA WOUND CLEANSER

    K Number: K103713 · Decision Jun 16, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    4
    Review Days
    177

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    Basic Information

    Device Name
    ELTA WOUND CLEANSER
    K Number
    K103713
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Swiss American Products, Inc.
    Date Received
    December 21, 2010
    Decision Date
    June 16, 2011
    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 Swiss American Products, Inc.

    K Number Device Name
    K073610 ELTA ADVANCED WOUND WASH
    K071703 ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC
    K932291 EUTRA GEL FOR WOUND DRESSING