Name: Predicase
Price: 199 USD

K-number	K172057
Device name	Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set
Applicant	Cook Ireland, Ltd.
Product code	FGE
Device class	Class II
Decision date	Mar 9, 2018
Decision	Substantially Equivalent
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set

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