Name: Predicase
Price: 199 USD

K-number	K142900
Device name	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
Applicant	Sofradim Production
Product code	FTL
Device class	Class II
Decision date	Oct 28, 2014
Decision	Substantially Equivalent
Regulation	878.3300

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Source

View the full FDA submission: accessdata.fda.gov

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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

Everything you need for a 510(k) submission. Nothing you don't.