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510(k) K110269

WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL by Well Lead Medical Co., Ltd. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2011
Date Received
January 27, 2011
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

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