K-number	K915761
Device name	BIVONA-COLORADO VOICE PROSTHESIS
Applicant	Bivona Medical Technologies
Product code	EWL
Device class	Class II
Decision date	Jun 29, 1992
Decision	Substantially Equivalent
Regulation	874.3730

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View the full FDA submission: accessdata.fda.gov

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BIVONA-COLORADO VOICE PROSTHESIS

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