Name: Predicase
Price: 199 USD

K-number	K944451
Device name	PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES)
Applicant	Passy-Muir, Inc.
Product code	JOH
Device class	Class II
Decision date	Jul 7, 1995
Decision	Substantially Equivalent
Regulation	868.5800

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Source

View the full FDA submission: accessdata.fda.gov

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PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES)

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