Kurz Upper Eyelid Implant Sizers, Model 8000 111

510(k) Number

K001123 ↗

FDA Product Code

MML

Device Class

Class II

Regulation

21 CFR Part 886.5700

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K011115 Active Cleared 2 May 2001

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  CE/MDD FDA 510(k) K021479 Active Cleared 21 May 2002

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  CE/MDD FDA 510(k) K130512 Active Cleared 2 Dec 2013

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  Class II

  CE/MDD FDA 510(k) K071150 Active Cleared 12 Dec 2007

• Kurz Pure Gold Upper Eyelids Implant (Oberascher), Model 4001 02-4001 10

  Class II

  FDA 510(k) K000127 Active Cleared 12 Apr 2000

• Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with Ene/S, Diabolo Tympanic Ventilation Tube, Minimal T)

  Class II

  FDA 510(k) K973226 Active Cleared 4 Nov 1997

See all devices from Heinz Kurz GmbH Medizintechnik →