K-number	K011210
Device name	THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY
Applicant	Rusch Intl.
Product code	JOH
Device class	Class II
Decision date	Aug 15, 2001
Decision	Substantially Equivalent
Regulation	868.5800

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Source

View the full FDA submission: accessdata.fda.gov

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THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY

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