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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 32 Results
ProductCode: FTL Applicant: SOFRADIM PRODUCTION Decision Date To: 10/01/2022
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parietene macroporous mesh Sofradim Production K223218 12/02/2022
symbotex composite mesh, progrip self-gripping polyester mesh, parietex hydrophilic 2d 3d anatomical mesh, versatex monofilament mesh Sofradim Production K220586 06/22/2022
dextile anatomical mesh Sofradim Production K192443 12/06/2019
duatene bilayer mesh Sofradim Production K172395 02/01/2018
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
parietene ds composite mesh Sofradim Production K163212 06/29/2017
versatex monofilament mesh SOFRADIM PRODUCTION K150091 05/26/2015
parietene macroporous mesh SOFRADIM PRODUCTION K142091 10/17/2014
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 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