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510(k) K170720

Portex Blue Line Ultra Paediatric Tracheosomy Tube by Smiths Medical Asd, Inc. — Product Code JOH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2017
Date Received
March 9, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube Tracheostomy And Tube Cuff
Device Class
Class II
Regulation Number
868.5800
Review Panel
AN
Submission Type

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  • K182861 — Shiley Neonatal/Pediatric Tracheostomy Tube (March 22, 2019)
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  • K180034 — Weinmann Tracheostomy Exchange Set (May 7, 2018)
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