K-number	K111843
Device name	ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM
Applicant	Smith & Nephew Inc., Endoscopy Div.
Product code	OLO
Device class	Class II
Decision date	Nov 14, 2011
Decision	Substantially Equivalent
Regulation	882.4560

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View the full FDA submission: accessdata.fda.gov

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ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM

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