Name: Predicase
Price: 199 USD

K-number	K081086
Device name	PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0
Applicant	Smiths Medical Asd, Inc.
Product code	BTR
Device class	Class II
Decision date	Aug 13, 2008
Decision	Substantially Equivalent
Regulation	868.5730

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Source

View the full FDA submission: accessdata.fda.gov

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PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0

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