K-number	K100995
Device name	SHIKANI SPEAKING VALVE
Applicant	Shikani Medical, LLC
Product code	JOH
Device class	Class II
Decision date	Jun 25, 2010
Decision	Substantially Equivalent
Regulation	868.5800

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Source

View the full FDA submission: accessdata.fda.gov

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SHIKANI SPEAKING VALVE

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