BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING

    K Number: K963656 · Decision Nov 12, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    79
    Registration Numbers
    79
    Same Product Code
    221
    Applicant Total
    6
    Review Days
    61

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    Basic Information

    Device Name
    FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING
    K Number
    K963656
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5090
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Adri
    Date Received
    September 12, 1996
    Decision Date
    November 12, 1996
    Product Code
    KMF
    Advisory Committee
    General Hospital
    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
    KMF Bandage, Liquid

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    Other Clearances by Adri

    K Number Device Name
    K041268 SILVERSITE OR CALGITROL
    K011618 CALGITROL AG SILVER ALGINATE WOUND DRESSING
    K000054 FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN
    K940404 ALGINATE FIBER TOPICAL WOUND DRESSING
    K870383 ALGINATE WOOL FIBER