Name: Predicase
Price: 199 USD

K-number	K172217
Device name	Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath
Applicant	Cook Incorporated
Product code	FED
Device class	Class II
Decision date	Dec 13, 2017
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath

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