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FDA 510(k) Application Details - K974902
Device Classification Name
Needle, Fistula
More FDA Info for this Device
510(K) Number
K974902
Device Name
Needle, Fistula
Applicant
JMS CO., LTD.
12-17, KAKO-MACHI, NAKA-KU
HIROSHIMA 730-8652 JP
Other 510(k) Applications for this Company
Contact
TETSUHARN HIROSE
Other 510(k) Applications for this Contact
Regulation Number
876.5540
More FDA Info for this Regulation Number
Classification Product Code
FIE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/30/1997
Decision Date
03/30/1998
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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