Name: Predicase
Price: 199 USD

K-number	K081440
Device name	BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES
Applicant	Smiths Medical Asd, Inc.
Product code	JOH
Device class	Class II
Decision date	Sep 12, 2008
Decision	Substantially Equivalent
Regulation	868.5800

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Source

View the full FDA submission: accessdata.fda.gov

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BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES

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