Name: Predicase
Price: 199 USD

K-number	K172807
Device name	Silicone Foley Catheter for single use
Applicant	Changzhou Rongxin Medicine Minimal Invasion Technology
Product code	EZL
Device class	Class II
Decision date	Jun 4, 2018
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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Silicone Foley Catheter for single use

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