Name: Predicase
Price: 199 USD

K-number	K192164
Device name	Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR
Applicant	Olympus Medical Systems Corp.
Product code	EOQ
Device class	Class II
Decision date	Mar 6, 2020
Decision	Substantially Equivalent
Regulation	874.4680

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Source

View the full FDA submission: accessdata.fda.gov

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Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR

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