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

    VASHE WOUND CLEANSING SYSTEM

    K Number: K093155 · Decision Mar 1, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    10
    Review Days
    146

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    Basic Information

    Device Name
    VASHE WOUND CLEANSING SYSTEM
    K Number
    K093155
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Puricore, Inc.
    Date Received
    October 6, 2009
    Decision Date
    March 1, 2010
    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 Puricore, Inc.

    K Number Device Name
    K141863 PURICORE WOUND HYDROGEL SPRAY DRESSING
    K131848 VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ)
    K123072 VASHE WOUND THERAPY SOLUTION
    K123071 VASHE SKIN AND WOUND HYDROGEL
    K100918 VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014
    K093697 VASHE WOUND THERAPY SOLUTION
    K092232 MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014
    K063159 STERILOX LIQUID CHEMICAL STERILANT SYSTEM
    K061689 AQUATINE EC ENDODONTIC CLEANSER