Name: Predicase
Price: 199 USD

K-number	K960680
Device name	RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, & EDR-P1
Applicant	Resound Corp.
Product code	ESD
Device class	Class I
Decision date	Apr 10, 1996
Decision	Substantially Equivalent
Regulation	874.3300

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Source

View the full FDA submission: accessdata.fda.gov

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RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, & EDR-P1

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