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510(k) K051993

LMA FASTRACH ETT SINGLE USE by The Laryngeal Mask Co., Ltd. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2005
Date Received
July 25, 2005
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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  • K991580 — ILM ENDOTRACHEAL TUBE (February 4, 2000)

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