FDA 510(k) Application Details - K111401

Device Classification Name Tube, Tracheal (W/Wo Connector)

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510(K) Number K111401
Device Name Tube, Tracheal (W/Wo Connector)
Applicant HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
NO. 8-1, LONGQUAN ROAD
CANGQIAN TOWN, YUHANG DISTRICT
HANGZHOU, ZHEJIANG 311121 CN
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Contact ALLYSON ZHOU
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Regulation Number 868.5730

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Classification Product Code BTR
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Date Received 05/19/2011
Decision Date 07/19/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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