Name: Predicase
Price: 199 USD

K-number	K123028
Device name	VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH
Applicant	Caldera Medical, Inc.
Product code	OTO
Device class	Class II
Decision date	Apr 25, 2013
Decision	Substantially Equivalent
Regulation	878.3300

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Source

View the full FDA submission: accessdata.fda.gov

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VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH

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