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FDA 510(k) Application Details - K983707
Device Classification Name
Accessories, Blood Circuit, Hemodialysis
More FDA Info for this Device
510(K) Number
K983707
Device Name
Accessories, Blood Circuit, Hemodialysis
Applicant
JMS CO., LTD.
12-17, KAKO-MACHI, NAKA-KU
HIROSHIMA 730-8652 JP
Other 510(k) Applications for this Company
Contact
TETSUHARU HIROSE
Other 510(k) Applications for this Contact
Regulation Number
876.5820
More FDA Info for this Regulation Number
Classification Product Code
KOC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/21/1998
Decision Date
01/08/1999
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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