K-number	K050496
Device name	REM440
Applicant	Interacoustics A/S, Assens
Product code	ETW
Device class	Class II
Decision date	Apr 29, 2005
Decision	Substantially Equivalent
Regulation	874.3310

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View the full FDA submission: accessdata.fda.gov

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REM440

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