K-number	K100480
Device name	ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
Applicant	Vitaltec Corporation
Product code	BTO
Device class	Class II
Decision date	Jun 11, 2010
Decision	Substantially Equivalent
Regulation	868.5800

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View the full FDA submission: accessdata.fda.gov

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ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH

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