K-number	K072715
Device name	REALHAND HIGH DEXTERITY INSTRUMENTS
Applicant	Novare Surgical Systems, Inc.
Product code	GCJ
Device class	Class II
Decision date	Oct 16, 2007
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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REALHAND HIGH DEXTERITY INSTRUMENTS

Everything you need for a 510(k) submission. Nothing you don't.