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U.S. Department of Health and Human Services

510(k) Premarket Notification
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ProductCode: JOH Applicant: PORTEX, INC. Decision Date To: 12/06/2022
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per-fit percutaneous dilational tracheostomy kit PORTEX, INC. K031057 07/18/2003
per-fit percutaneous dilational tracheostomy kit with specialty tracheostomy tube and disposable inner cannula SIMS PORTEX, INC. K980466 02/24/1998
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