K-number	K930105
Device name	BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.
Applicant	Helix Medical, Inc.
Product code	EWL
Device class	Class II
Decision date	May 17, 1993
Decision	Substantially Equivalent
Regulation	874.3730

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BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.

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