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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 K111406
Device Name BEVER REINFORCED ENDOTRACHEAL TUBE WITH CUFF (ORAL/NASAL), BEVER REINFORCED ENDOTRACHEAL TUBE WITHOUT CUFF (ORAL/NASAL)
Applicant
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
NO. 8-1, LONGQUAN ROAD
CANGQIAN TOWN, YUHANG DISTRICT
HANGZHOU, ZHEJIANG,  CN 311121
Applicant Contact ALLYSON ZHOU
Correspondent
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
NO. 8-1, LONGQUAN ROAD
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
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