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

    FRAG COMMANDER

    K Number: K973749 · Decision Dec 8, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    5
    Review Days
    68

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    Basic Information

    Device Name
    FRAG COMMANDER
    K Number
    K973749
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Scieran Technologies, Inc.
    Date Received
    October 1, 1997
    Decision Date
    December 8, 1997
    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 Scieran Technologies, Inc.

    K Number Device Name
    K974253 CPD COMMANDER
    K980085 PHACO COMMANDER
    K961738 VIT COMMANDER SYSTEM
    K960767 LIGHT COMMANDER