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

    CREAT BRAND O-RISE GENERAL ASPIRATOR

    K Number: K873940 · Decision Nov 25, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    6
    Review Days
    58

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    Basic Information

    Device Name
    CREAT BRAND O-RISE GENERAL ASPIRATOR
    K Number
    K873940
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Aesthetech Corp.
    Date Received
    September 28, 1987
    Decision Date
    November 25, 1987
    Product Code
    BTA
    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
    BTA Pump, Portable, Aspiration (Manual Or Powered)

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    Other Clearances by Aesthetech Corp.

    K Number Device Name
    K873434 CREAT BRAND MALAR IMPLANT
    K853189 CREAT BRAND I/A PACK CREAT BRAND PHACO PACK
    K843678 CREAT BRAND SKIN EXPANDER
    K841283 DISPOSABLE SUCTION TUBING SET
    K812210 CREAT BRAND WAGNER CHIN IMPLANT