Name: Predicase
Price: 199 USD

K-number	K171604
Device name	Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip
Applicant	Cook Incorporated
Product code	LKF
Device class	Class II
Decision date	Feb 15, 2018
Decision	Substantially Equivalent
Regulation	884.4530

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip

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