Name: Predicase
Price: 199 USD

K-number	K033341
Device name	SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
Applicant	Smith & Nephew, Inc.
Product code	HAW
Device class	Class II
Decision date	Sep 10, 2004
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS

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