K-number	K181632
Device name	Venacure 1470 Pro
Applicant	Quanta System Spa
Product code	GEX
Device class	Class II
Decision date	Sep 17, 2018
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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Venacure 1470 Pro

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