Name: Predicase
Price: 199 USD

K-number	K080402
Device name	ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38
Applicant	Encore Medical L.P.
Product code	KWS
Device class	Class II
Decision date	Mar 28, 2008
Decision	Substantially Equivalent
Regulation	888.3660

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Source

View the full FDA submission: accessdata.fda.gov

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ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38

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