Name: Predicase
Price: 199 USD

K-number	K033830
Device name	OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000
Applicant	Opticon Medical, Inc.
Product code	EZL
Device class	Class II
Decision date	Jan 9, 2004
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000

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