K-number	K991587
Device name	BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS
Applicant	Helix Medical, Inc.
Product code	EWL
Device class	Class II
Decision date	Jun 25, 1999
Decision	Substantially Equivalent
Regulation	874.3730

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View the full FDA submission: accessdata.fda.gov

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BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS

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