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

    CREAT BRAND SKIN EXPANDER

    K Number: K843678 · Decision Nov 6, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    54
    Applicant Total
    6
    Review Days
    49

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    Basic Information

    Device Name
    CREAT BRAND SKIN EXPANDER
    K Number
    K843678
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Aesthetech Corp.
    Date Received
    September 18, 1984
    Decision Date
    November 6, 1984
    Product Code
    LCJ
    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
    LCJ Tissue Expander And Accessories

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    Other Clearances by Aesthetech Corp.

    K Number Device Name
    K873940 CREAT BRAND O-RISE GENERAL ASPIRATOR
    K873434 CREAT BRAND MALAR IMPLANT
    K853189 CREAT BRAND I/A PACK CREAT BRAND PHACO PACK
    K841283 DISPOSABLE SUCTION TUBING SET
    K812210 CREAT BRAND WAGNER CHIN IMPLANT