K-number	K061459
Device name	TRANQUIL TRI-BTE
Applicant	General Hearing Instruments, Inc.
Product code	KLW
Device class	Class II
Decision date	Jun 30, 2006
Decision	Substantially Equivalent
Regulation	874.3400

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Source

View the full FDA submission: accessdata.fda.gov

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TRANQUIL TRI-BTE

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