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

    FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN

    K Number: K000054 · Decision Mar 13, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    187
    Applicant Total
    6
    Review Days
    66

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    Basic Information

    Device Name
    FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN
    K Number
    K000054
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Adri
    Date Received
    January 7, 2000
    Decision Date
    March 13, 2000
    Product Code
    KGN
    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
    KGN Wound Dressing With Animal-Derived Material(S)

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    Other Clearances by Adri

    K Number Device Name
    K041268 SILVERSITE OR CALGITROL
    K011618 CALGITROL AG SILVER ALGINATE WOUND DRESSING
    K963656 FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING
    K940404 ALGINATE FIBER TOPICAL WOUND DRESSING
    K870383 ALGINATE WOOL FIBER