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510(k) K200761

Tenax Laser Resistant Endotracheal Tube by Bryan Medical, Inc. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2020
Date Received
March 24, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type

Other clearances by Bryan Medical, Inc.

  • K213028 — Tenax Laser Resistant Endotracheal Tube (October 21, 2021)
  • K150951 — aeris Balloon Dialation Catheter (June 25, 2015)

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