Name: Predicase
Price: 199 USD

K-number	K131053
Device name	ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM
Applicant	The Anspach Effort, Inc.
Product code	ERL
Device class	Class II
Decision date	Dec 31, 2013
Decision	Substantially Equivalent
Regulation	874.4250

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Source

View the full FDA submission: accessdata.fda.gov

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ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM

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