Name: Predicase
Price: 199 USD

K-number	K132389
Device name	CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED
Applicant	Daniel & Daniel Consulting
Product code	OWN
Device class	Class II
Decision date	Feb 25, 2014
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED

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