K-number	K040947
Device name	DURASUL BIPOLAR
Applicant	Centerpulse Orthopedics, Inc.
Product code	KWY
Device class	Class II
Decision date	Aug 27, 2004
Decision	Substantially Equivalent
Regulation	888.3390

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View the full FDA submission: accessdata.fda.gov

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DURASUL BIPOLAR

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