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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K014140
Device Name RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET
Applicant
Sunder Biomedical Tech. Co., Ltd.
10f-1, 1-67, Wu-Chuan Rd.
Taichung City,  TW 403
Applicant Contact TONY HUNG
Correspondent
Sunder Biomedical Tech. Co., Ltd.
10f-1, 1-67, Wu-Chuan Rd.
Taichung City,  TW 403
Correspondent Contact TONY HUNG
Regulation Number876.5820
Classification Product Code
FJK  
Date Received12/17/2001
Decision Date 11/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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