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

    AUTOMATED HYDROSONICS(TM)

    K Number: K902798 · Decision Aug 28, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    3
    Review Days
    62

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    Basic Information

    Device Name
    AUTOMATED HYDROSONICS(TM)
    K Number
    K902798
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Alcon Surgical, Inc.
    Date Received
    June 27, 1990
    Decision Date
    August 28, 1990
    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 Alcon Surgical, Inc.

    K Number Device Name
    K901275 RETINAL TAAK
    K897099 MODEL 2800 ND:YAG OPHTHALMIC LASER