Name: Predicase
Price: 199 USD

K-number	K122932
Device name	SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
Applicant	Fogless International AB
Product code	JOH
Device class	Class II
Decision date	Dec 23, 2013
Decision	Substantially Equivalent
Regulation	868.5800

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Source

View the full FDA submission: accessdata.fda.gov

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SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT

Everything you need for a 510(k) submission. Nothing you don't.