BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PERMAMESH-D HYDROXYLAPATITE MATRIX

    K Number: K960354 · Decision Mar 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    39
    Applicant Total
    16
    Review Days
    55

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    Basic Information

    Device Name
    PERMAMESH-D HYDROXYLAPATITE MATRIX
    K Number
    K960354
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ceramed Corp.
    Date Received
    January 25, 1996
    Decision Date
    March 20, 1996
    Product Code
    LZK
    Advisory Committee
    General, Plastic Surgery
    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
    LZK Implant, Malar

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    Other Clearances by Ceramed Corp.

    K Number Device Name
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    K960353 OSTEOGRAF/LD-300 HYDROXYLAPATITE
    K960368 OSTEOGRAFT/N-700 HYDROXYLAPTITE
    K960361 PERMAMESH-D HYDROXYLAPATITE MATRIX
    K960362 PERMAMESH HYDROXYLAPATITE MATRIX
    K960349 PERMARIDGE HYDROXYLAPATITE MATRIX
    K954631 OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE
    K942946 OSTEOGRAF/D-100 HYDROXYLAPATITE
    Search all 16 clearances from Ceramed Corp. →