K-number	K083814
Device name	OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120
Applicant	Cordis Corp., A Johnson & Johnson Co.
Product code	PDU
Device class	Class II
Decision date	Jan 13, 2009
Decision	Substantially Equivalent
Regulation	870.1250

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OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120

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