Name: Predicase
Price: 199 USD

K-number	K141991
Device name	SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP
Applicant	Olympus Medical Systems Copr.
Product code	KNS
Device class	Class II
Decision date	Mar 31, 2015
Decision	Substantially Equivalent
Regulation	876.4300

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Source

View the full FDA submission: accessdata.fda.gov

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SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP

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