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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, straight
510(k) Number K151745
Device Name FULL CARE Disposable PVC Nelaton Catheter
Applicant
SHAOXING FUQING HEALTH PRODUCTS CO., LTD.
NO. 599 WUXIE ROAD,
SHAOXING HIGH-TECH INDUSTRIAL DEVELOPMENT ZONE
SHAOXING,  CN 312000
Applicant Contact DEAN WU
Correspondent
GUANGZHOU OSMUNDA MEDICAL DEVICE TECHNOLOGY SERVICE CO., LTD
7TH FLOOR, JINGUI BUSINESS BUILDING BAIYUM DISTRICT
GUANGZHOU,  CN 510420
Correspondent Contact MIKE GU
Regulation Number876.5130
Classification Product Code
EZD  
Subsequent Product Codes
FCM   GBM  
Date Received06/29/2015
Decision Date 03/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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