K-number	K111558
Device name	SURGICASE GUIDE
Applicant	Materialise NV
Product code	HAW
Device class	Class II
Decision date	Mar 27, 2012
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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SURGICASE GUIDE

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