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

    COLACTIVE COLLAGEN WOUND DRESSING

    K Number: K050177 · Decision Apr 27, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    187
    Applicant Total
    6
    Review Days
    91

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    Basic Information

    Device Name
    COLACTIVE COLLAGEN WOUND DRESSING
    K Number
    K050177
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Covalontechnologies, Inc.
    Date Received
    January 26, 2005
    Decision Date
    April 27, 2005
    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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    K112549 IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
    K043296 COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING