K-number	K810020
Device name	PANJE VOICE PROSTHESIS
Applicant	Xomed, Inc.
Product code	EWL
Device class	Class II
Decision date	Feb 5, 1981
Decision	Substantially Equivalent
Regulation	874.3730

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Source

View the full FDA submission: accessdata.fda.gov

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PANJE VOICE PROSTHESIS

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