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

    CREAT BRAND I/A PACK CREAT BRAND PHACO PACK

    K Number: K853189 · Decision Sep 24, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    6
    Review Days
    56

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    Basic Information

    Device Name
    CREAT BRAND I/A PACK CREAT BRAND PHACO PACK
    K Number
    K853189
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Aesthetech Corp.
    Date Received
    July 30, 1985
    Decision Date
    September 24, 1985
    Product Code
    HQC
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HQC Unit, Phacofragmentation

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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
    K843678 CREAT BRAND SKIN EXPANDER
    K841283 DISPOSABLE SUCTION TUBING SET
    K812210 CREAT BRAND WAGNER CHIN IMPLANT