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.
Device ID | K014140 |
510k Number | K014140 |
Device Name: | RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET |
Classification | Set, 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 |
Contact | Tony Hung |
Correspondent | Tony Hung SUNDER BIOMEDICAL TECH. CO., LTD. 10F-1, 1-67, WU-CHUAN RD. Taichung City, TW 403 |
Product Code | FJK |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-12-17 |
Decision Date | 2002-11-18 |