K-number	K142986
Device name	SagiNova
Applicant	Eckert & Ziegler Bebig GmbH
Product code	JAQ
Device class	Class II
Decision date	Apr 17, 2015
Decision	Substantially Equivalent
Regulation	892.5700

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Source

View the full FDA submission: accessdata.fda.gov

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SagiNova

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