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

    PHACOGARD

    K Number: K002932 · Decision Jan 4, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    3
    Review Days
    106

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    Basic Information

    Device Name
    PHACOGARD
    K Number
    K002932
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Syntec, Inc.
    Date Received
    September 20, 2000
    Decision Date
    January 4, 2001
    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 Syntec, Inc.

    K Number Device Name
    K980480 SYNTEC VITMAN
    K971338 SYNTEC, INC. DISPOSABLE BARE END FIBER