Name: Predicase
Price: 199 USD

K-number	K180829
Device name	PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh
Applicant	ETHICON, Inc.
Product code	FTL
Device class	Class II
Decision date	Jun 28, 2018
Decision	Substantially Equivalent
Regulation	878.3300

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Source

View the full FDA submission: accessdata.fda.gov

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PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh

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