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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: 12/04/2021
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parietene polypropylene mesh SOFRADIM PRODUCTION K991400 07/12/1999
sofradim parietex surgical meshes SOFRADIM PRODUCTION K003990 01/24/2001
ugytex mesh SOFRADIM PRODUCTION K033376 01/15/2004
modification to parietex composite (pco) mesh SOFRADIM PRODUCTION K040998 04/29/2004
parietex composite pco-os and pco-ob meshes SOFRADIM PRODUCTION K050187 02/18/2005
parietex polyester mesh with introducer SOFRADIM PRODUCTION K071629 07/10/2007
prevadh mesh SOFRADIM PRODUCTION K073287 03/13/2008
parietex progrip mesh SOFRADIM PRODUCTION K081050 05/28/2008
parietex composite mono pm mesh SOFRADIM PRODUCTION K081126 08/13/2008
parietex monofilament polyester mesh SOFRADIM PRODUCTION K090858 05/06/2009