Name: Predicase
Price: 199 USD

K-number	K122422
Device name	PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER
Applicant	Care Fusion
Product code	PNG
Device class	Class II
Decision date	Oct 24, 2012
Decision	Unknown
Regulation	876.5630

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Source

View the full FDA submission: accessdata.fda.gov

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PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER

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