K-number	K982128
Device name	SHIKANI-FRENCH SPEAKING VALVE
Applicant	Pilling Weck Surgical
Product code	JOH
Device class	Class II
Decision date	Oct 23, 1998
Decision	Substantially Equivalent
Regulation	868.5800

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View the full FDA submission: accessdata.fda.gov

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SHIKANI-FRENCH SPEAKING VALVE

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