Name: Predicase
Price: 199 USD

K-number	K063442
Device name	ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR
Applicant	Degania Silicone , Ltd.
Product code	EZL
Device class	Class II
Decision date	Mar 26, 2007
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR

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