Name: Predicase
Price: 199 USD

K-number	K093469
Device name	CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS
Applicant	Cook, Inc.
Product code	JOH
Device class	Class II
Decision date	Jan 8, 2010
Decision	Substantially Equivalent
Regulation	868.5800

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Source

View the full FDA submission: accessdata.fda.gov

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CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS

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