Name: Predicase
Price: 199 USD

K-number	K121510
Device name	IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER
Applicant	Covidien, Formerly US Surgical A Divison of Tyco H
Product code	GDW
Device class	Class II
Decision date	Jul 25, 2012
Decision	Substantially Equivalent
Regulation	878.4750

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Source

View the full FDA submission: accessdata.fda.gov

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IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER

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