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

    SENTREX BIOSPONGE MPD

    K Number: K123961 · Decision Apr 5, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    402
    Registration Numbers
    403
    Same Product Code
    861
    Applicant Total
    2
    Review Days
    100

    Basic Information

    Device Name
    SENTREX BIOSPONGE MPD
    K Number
    K123961
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BIONOVA MEDICAL, INC
    Date Received
    December 26, 2012
    Decision Date
    April 5, 2013
    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 BIONOVA MEDICAL, INC

    K Number Device Name
    K112191 HEALEX BIOSPONGE WOUND DRESSING