Name: Predicase
Price: 199 USD

K-number	K972385
Device name	FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED
Applicant	Smiths Industries Medical Systems, Inc.
Product code	JOH
Device class	Class II
Decision date	Jan 20, 1998
Decision	Substantially Equivalent
Regulation	868.5800

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Source

View the full FDA submission: accessdata.fda.gov

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FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED

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