BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111

    K Number: K001123 · Decision Apr 21, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    13
    Applicant Total
    14
    Review Days
    14

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    Basic Information

    Device Name
    KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111
    K Number
    K001123
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5700
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Heinz Kurz GmbH Medizintechnik
    Date Received
    April 7, 2000
    Decision Date
    April 21, 2000
    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

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    Other Clearances by Heinz Kurz GmbH Medizintechnik

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    K042503 KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM
    K033796 KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS
    K021479 CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861
    K013573 CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257
    K011115 KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010
    K002221 KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170
    K000127 KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10
    Search all 14 clearances from Heinz Kurz GmbH Medizintechnik →