Name: Predicase
Price: 199 USD

K-number	K040014
Device name	PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY
Applicant	Portex , Ltd.
Product code	JOH
Device class	Class II
Decision date	Feb 13, 2004
Decision	Substantially Equivalent
Regulation	868.5800

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View the full FDA submission: accessdata.fda.gov

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PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY

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