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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 32 Results
ProductCode: FTL Applicant: SOFRADIM PRODUCTION Decision Date To: 10/01/2022
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parietex surgical mesh (modified into parietex hydrophilic 2d, 3d, anatomical mesh), parietex composite mesh (pco and pco-os references), parietex optimized composite mesh (pco-x, pco-fx and pco-osx references) Sofradim Production K173796 03/09/2018
parietex progrip mesh (new name: progrip self-gripping polyester mesh), parietex plug and patch (new name : parietex plug and patch system), progrip laparoscopic self-fixating mesh SOFRADIM PRODUCTION K142900 10/28/2014
parietex progrip mesh SOFRADIM PRODUCTION K081050 05/28/2008
parietex progrip SOFRADIM PRODUCTION K103682 03/04/2011
parietex polyester mesh with introducer SOFRADIM PRODUCTION K071629 07/10/2007
parietex plug and patch SOFRADIM PRODUCTION K101519 11/05/2010
parietex optimized compostie mesh SOFRADIM PRODUCTION K110815 04/19/2011
parietex optimized composite mesh (pco-osx references) SOFRADIM PRODUCTION K110816 04/19/2011
parietex monofilament polyester mesh (new name: parietex lightweight mesh), parietex composite mono pm mesh (new name: parietex composite parastomal mesh), parietex composite ventral patch, symbotex composite mesh SOFRADIM PRODUCTION K142908 11/14/2014
parietex monofilament polyester mesh SOFRADIM PRODUCTION K090858 05/06/2009