K-number	K112134
Device name	TRUCLEAR OPERATIVE HYSTEROSCOPE
Applicant	Smith & Nephew, Inc.
Product code	HIH
Device class	Class II
Decision date	Nov 22, 2011
Decision	Substantially Equivalent
Regulation	884.1690

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View the full FDA submission: accessdata.fda.gov

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TRUCLEAR OPERATIVE HYSTEROSCOPE

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