K-number	K940638
Device name	PROVOX(TM) VOICE PROSTHESIS
Applicant	Atos Medical AB
Product code	EWL
Device class	Class II
Decision date	Jun 22, 1994
Decision	Substantially Equivalent
Regulation	874.3730

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Source

View the full FDA submission: accessdata.fda.gov

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PROVOX(TM) VOICE PROSTHESIS

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