Name: Predicase
Price: 199 USD

K-number	K091759
Device name	SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H
Applicant	Olympus Medical Systems Corporation
Product code	KNT
Device class	Class II
Decision date	Sep 18, 2009
Decision	Substantially Equivalent
Regulation	876.5980

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Source

View the full FDA submission: accessdata.fda.gov

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SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H

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