Name: Predicase
Price: 199 USD

K-number	K051587
Device name	TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
Applicant	Tracoe Medical GmbH
Product code	BTO
Device class	Class II
Decision date	Oct 25, 2005
Decision	Substantially Equivalent
Regulation	868.5800

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Source

View the full FDA submission: accessdata.fda.gov

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TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470

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