Name: Predicase
Price: 199 USD

K-number	K101900
Device name	HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH
Applicant	Hakki Medical Technologies, Inc.
Product code	GBM
Device class	Class II
Decision date	Feb 7, 2011
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH

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