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

    UNITE BIOMATRIX

    K Number: K071425 · Decision Jun 20, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    187
    Applicant Total
    5
    Review Days
    28

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    Basic Information

    Device Name
    UNITE BIOMATRIX
    K Number
    K071425
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pegasus Biologics, Inc.
    Date Received
    May 23, 2007
    Decision Date
    June 20, 2007
    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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    Other Clearances by Pegasus Biologics, Inc.

    K Number Device Name
    K090288 ORTHADAPT PR
    K071065 ORTHADAPT BIOIMPLANT
    K061494 DERMADAPT WOUND DRESSING
    K043388 PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH