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510(k) K991580

ILM ENDOTRACHEAL TUBE by The Laryngeal Mask Co., Ltd. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2000
Date Received
May 7, 1999
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 The Laryngeal Mask Co., Ltd.

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  • K062475 — LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM (May 9, 2007)
  • K051993 — LMA FASTRACH ETT SINGLE USE (December 13, 2005)

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