FDA 510(k) Application Details - K151745

Device Classification Name Catheter, Straight

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510(K) Number K151745
Device Name Catheter, Straight
Applicant SHAOXING FUQING HEALTH PRODUCTS CO., LTD.
NO. 599 WUXIE ROAD,
SHAOXING HIGH-TECH INDUSTRIAL DEVELOPMENT ZONE
SHAOXING 312000 CN
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Contact DEAN WU
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Regulation Number 876.5130

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Classification Product Code EZD
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Date Received 06/29/2015
Decision Date 03/03/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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