K-number	K912124
Device name	TRACHEOSTOMY TUBE AND CUFF
Applicant	Concord/Portex
Product code	BTO
Device class	Class II
Decision date	Aug 16, 1991
Decision	Substantially Equivalent
Regulation	868.5800

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View the full FDA submission: accessdata.fda.gov

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TRACHEOSTOMY TUBE AND CUFF

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