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FDA 510(k) Application Details - K014140
Device Classification Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
More FDA Info for this Device
510(K) Number
K014140
Device Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Applicant
SUNDER BIOMEDICAL TECH. CO., LTD.
10F-1, 1-67, WU-CHUAN RD.
TAICHUNG CITY 403 TW
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Contact
TONY HUNG
Other 510(k) Applications for this Contact
Regulation Number
876.5820
More FDA Info for this Regulation Number
Classification Product Code
FJK
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More FDA Info for this Product Code
Date Received
12/17/2001
Decision Date
11/18/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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