Name: Predicase
Price: 199 USD

K-number	K210833
Device name	Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
Applicant	Smiths Medical Asd, Inc.
Product code	JOH
Device class	Class II
Decision date	Nov 26, 2021
Decision	Substantially Equivalent
Regulation	868.5800

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Source

View the full FDA submission: accessdata.fda.gov

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Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula

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