Name: Predicase
Price: 199 USD

K-number	K090628
Device name	DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080
Applicant	Bayer Healthcare, LLC
Product code	NBW
Device class	Class II
Decision date	Dec 4, 2009
Decision	Substantially Equivalent
Regulation	862.1345

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Source

View the full FDA submission: accessdata.fda.gov

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DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080

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