K-number	K152143
Device name	TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
Applicant	Smith & Nephew, Inc.
Product code	HIH
Device class	Class II
Decision date	Sep 2, 2015
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 5C and Sheath 5C

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