Name: Predicase
Price: 199 USD

K-number	K160241
Device name	Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
Applicant	Olympus Medical Systems Corp.
Product code	KNS
Device class	Class II
Decision date	Mar 2, 2016
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 Sphincterotome V (Distal Wireguided) KD-VC412Q-0215

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