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

    PURACYN PLUS SKIN AND WOUND

    K Number: K133542 · Decision Apr 28, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    4
    Review Days
    161

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    Basic Information

    Device Name
    PURACYN PLUS SKIN AND WOUND
    K Number
    K133542
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Innovacyn, Inc.
    Date Received
    November 18, 2013
    Decision Date
    April 28, 2014
    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 Innovacyn, Inc.

    K Number Device Name
    K251757 Puracyn® Plus Antimicrobial Irrigation Solution
    K232080 Puracyn® Plus Antimicrobial Irrigation Solution
    K150799 Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula