Name: Predicase
Price: 199 USD

K-number	K082206
Device name	BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES
Applicant	Helix Medical, LLC
Product code	EWL
Device class	Class II
Decision date	Sep 4, 2008
Decision	Substantially Equivalent
Regulation	874.3730

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Source

View the full FDA submission: accessdata.fda.gov

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BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES

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