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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K111401
Device Name BEVER ENDOTRACHEAL TUBE, BEVER EVA ENDOTRACHEAL TUBE
Applicant
Hangzhou Bever Medical Devices Co., Ltd.
# 8-1, Longquan Rd.
Cangqian Town, Yuhang District
Hangzhou, Zhejiang,  CN 311121
Applicant Contact ALLYSON ZHOU
Correspondent
Hangzhou Bever Medical Devices Co., Ltd.
# 8-1, Longquan Rd.
Cangqian Town, Yuhang District
Hangzhou, Zhejiang,  CN 311121
Correspondent Contact ALLYSON ZHOU
Regulation Number868.5730
Classification Product Code
BTR  
Date Received05/19/2011
Decision Date 07/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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