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

    CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)

    K Number: K011740 · Decision Jul 2, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    13
    Applicant Total
    2
    Review Days
    27

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000)
    K Number
    K011740
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.5700
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meddev Corp.
    Date Received
    June 5, 2001
    Decision Date
    July 2, 2001
    Product Code
    MML
    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
    MML Weights, Eyelid, External

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MML), ordered by most recent decision date.

    Altomed Malhotra Platinum Segments

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LID CHAIN EYELID WEIGHTS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SUTUREGROOVE WEIGHT SIZING SET

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all

    Other Clearances by Meddev Corp.

    K Number Device Name
    K940974 EYECLOSE EXTERNAL EYELID WEIGHTS