K-number	K111583
Device name	FLAATZ 560
Applicant	Drtech Corp.
Product code	MQB
Device class	Class II
Decision date	Oct 4, 2011
Decision	Substantially Equivalent
Regulation	892.1680

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Source

View the full FDA submission: accessdata.fda.gov

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FLAATZ 560

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