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

    CALGITROL AG SILVER ALGINATE WOUND DRESSING

    K Number: K011618 · Decision Nov 15, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    6
    Review Days
    539

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    Basic Information

    Device Name
    CALGITROL AG SILVER ALGINATE WOUND DRESSING
    K Number
    K011618
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Adri
    Date Received
    May 25, 2001
    Decision Date
    November 15, 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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    Other Clearances by Adri

    K Number Device Name
    K041268 SILVERSITE OR CALGITROL
    K000054 FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN
    K963656 FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING
    K940404 ALGINATE FIBER TOPICAL WOUND DRESSING
    K870383 ALGINATE WOOL FIBER