BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇦 Canada

    IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER

    K Number: K112549 · Decision May 4, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    6
    Review Days
    246

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    Basic Information

    Device Name
    IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
    K Number
    K112549
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Covalontechnologies, Inc.
    Date Received
    September 1, 2011
    Decision Date
    May 4, 2012
    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 Covalontechnologies, Inc.

    K Number Device Name
    K163556 MediClear PreOp
    K150550 SilverCoat Silicone Foley Catheter
    K121819 SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
    K043296 COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING
    K050177 COLACTIVE COLLAGEN WOUND DRESSING