RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET

Set, Tubing, Blood, With And Without Anti-regurgitation Valve

SUNDER BIOMEDICAL TECH. CO., LTD.

The following data is part of a premarket notification filed by Sunder Biomedical Tech. Co., Ltd. with the FDA for Renax Hemodialysis Blood Tubing Set; Sunder Hemodialysis Blood Tubing Set.

Pre-market Notification Details

Device IDK014140
510k NumberK014140
Device Name:RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET
ClassificationSet, Tubing, Blood, With And Without Anti-regurgitation Valve
Applicant SUNDER BIOMEDICAL TECH. CO., LTD. 10F-1, 1-67, WU-CHUAN RD. Taichung City,  TW 403
ContactTony Hung
CorrespondentTony Hung
SUNDER BIOMEDICAL TECH. CO., LTD. 10F-1, 1-67, WU-CHUAN RD. Taichung City,  TW 403
Product CodeFJK  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-12-17
Decision Date2002-11-18

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