Name: Predicase
Price: 199 USD

K-number	K030381
Device name	PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
Applicant	Portex , Ltd.
Product code	BTO
Device class	Class II
Decision date	Aug 27, 2003
Decision	Substantially Equivalent
Regulation	868.5800

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Source

View the full FDA submission: accessdata.fda.gov

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PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA

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