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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 composite pco-os and pco-ob meshes SOFRADIM PRODUCTION K050187 02/18/2005
parietex composite ventral patch SOFRADIM PRODUCTION K120506 06/13/2012
parietex monofilament polyester mesh SOFRADIM PRODUCTION K090858 05/06/2009
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 optimized composite mesh (pco-osx references) SOFRADIM PRODUCTION K110816 04/19/2011
parietex optimized compostie mesh SOFRADIM PRODUCTION K110815 04/19/2011
parietex plug and patch SOFRADIM PRODUCTION K101519 11/05/2010
parietex polyester mesh with introducer SOFRADIM PRODUCTION K071629 07/10/2007
parietex progrip SOFRADIM PRODUCTION K103682 03/04/2011
parietex progrip mesh SOFRADIM PRODUCTION K081050 05/28/2008