K-number	K110973
Device name	IE-ZEN (IN CLEAR SERIES HEARING AID)
Applicant	Widex USA
Product code	KLW
Device class	Class II
Decision date	May 5, 2011
Decision	Substantially Equivalent
Regulation	874.3400

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View the full FDA submission: accessdata.fda.gov

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IE-ZEN (IN CLEAR SERIES HEARING AID)

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