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510(k) K160694

Disposable Endotracheal tube, sterile, AccuCuff by Tianjin Medis Medical Device Co., Ltd. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2017
Date Received
March 14, 2016
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 Tianjin Medis Medical Device Co., Ltd.

  • K190274 — Endotracheal Tube (July 30, 2019)
  • K182548 — Accucuff Cuff Pressure Indicator (January 25, 2019)

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