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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, urethral
510(k) Number K142767
Device Name ThinkMed Intermittent Catheter with/without Hydrophilic Coating
Applicant
ThinkMed Medical Technology Co., Ltd.
No.4 Building, 322 Hongyang Road, Qiandeng Town
Kunshan,  CN 215341
Applicant Contact Garfield Wang
Correspondent
ThinkMed Medical Technology Co., Ltd.
No.4 Building, 322 Hongyang Road, Qiandeng Town
Kunshan,  CN 215341
Correspondent Contact Garfield Wang
Regulation Number876.5130
Classification Product Code
GBM  
Date Received09/25/2014
Decision Date 02/03/2015
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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