Name: Predicase
Price: 199 USD

K-number	K193560
Device name	Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner
Applicant	Materialise NV
Product code	QHE
Device class	Class II
Decision date	Mar 20, 2020
Decision	Substantially Equivalent
Regulation	888.3660

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Source

View the full FDA submission: accessdata.fda.gov

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Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner

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