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U.S. Department of Health and Human Services

510(k) Premarket Notification
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21 to 30 of 32 Results
ProductCode: FTL Applicant: SOFRADIM PRODUCTION Decision Date To: 10/01/2022
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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 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
prevadh mesh SOFRADIM PRODUCTION K073287 03/13/2008
progrip laparoscopic self-fixating mesh SOFRADIM PRODUCTION K123479 12/11/2012
progrip laparoscopic self-fixating mesh SOFRADIM PRODUCTION K143386 03/13/2015
progrip laparscopic self-fixating mesh SOFRADIM PRODUCTION K120897 06/29/2012
progrip self-gripping polypropylene mesh, parietene flat sheet mesh SOFRADIM PRODUCTION K140941 05/07/2014
sofradim parietex surgical meshes SOFRADIM PRODUCTION K003990 01/24/2001
symbotex composite mesh, progrip self-gripping polyester mesh, parietex hydrophilic 2d 3d anatomical mesh, versatex monofilament mesh Sofradim Production K220586 06/22/2022
symbotex(tm) composite mesh SOFRADIM PRODUCTION K131969 08/22/2013
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