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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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dextile anatomical mesh Sofradim Production K192443 12/06/2019
duatene bilayer mesh Sofradim Production K172395 02/01/2018
modification to parietex composite (pco) mesh SOFRADIM PRODUCTION K040998 04/29/2004
pairetex optimized composite mesh (pco-fx refrences) SOFRADIM PRODUCTION K110663 08/11/2011
parie tene progrip mesh SOFRADIM PRODUCTION K101197 05/05/2010
parietene ds composite mesh Sofradim Production K163212 06/29/2017
parietene macroporous mesh SOFRADIM PRODUCTION K142091 10/17/2014
parietene macroporous mesh Sofradim Production K223218 12/02/2022
parietene polypropylene mesh SOFRADIM PRODUCTION K991400 07/12/1999
parietex composite mono pm mesh SOFRADIM PRODUCTION K081126 08/13/2008