Name: Predicase
Price: 199 USD

K-number	K010567
Device name	OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR
Applicant	C.R. Bard, Inc.
Product code	MSD
Device class	Class II
Decision date	Mar 28, 2001
Decision	Substantially Equivalent
Regulation	876.5540

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Source

View the full FDA submission: accessdata.fda.gov

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OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR

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