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

    ESSTECH PS ASPHERIC

    K Number: K942186 · Decision Jul 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    485
    Applicant Total
    4
    Review Days
    85

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    Basic Information

    Device Name
    ESSTECH PS ASPHERIC
    K Number
    K942186
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Szabocsik and Assoc.
    Date Received
    May 4, 1994
    Decision Date
    July 28, 1994
    Product Code
    LPL
    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
    LPL Lenses, Soft Contact, Daily Wear

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    Other Clearances by Szabocsik and Assoc.

    K Number Device Name
    K974485 SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION
    K951180 ESSTECH SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
    K942187 ESSTECH SV(POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS