K-number	K823749
Device name	LOW PRESSURE BLOM-SINGER VOICE PROSTHES
Applicant	Bivona Medical Technologies
Product code	EWL
Device class	Class II
Decision date	Jan 7, 1983
Decision	Substantially Equivalent
Regulation	874.3730

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View the full FDA submission: accessdata.fda.gov

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LOW PRESSURE BLOM-SINGER VOICE PROSTHES

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