K-number	K861088
Device name	BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS
Applicant	Bivona Medical Technologies
Product code	EWL
Device class	Class II
Decision date	Apr 2, 1986
Decision	Substantially Equivalent
Regulation	874.3730

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View the full FDA submission: accessdata.fda.gov

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BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS

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