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FDA 510(k) Application Details - K131721
Device Classification Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
More FDA Info for this Device
510(K) Number
K131721
Device Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
Applicant
COMED MEDICAL SYSTEMS CO., LTD
11874 SOUTH EVELYN CIRCLE
HOUSTON, TX 77071 US
Other 510(k) Applications for this Company
Contact
J. HARVEY KNAUSS
Other 510(k) Applications for this Contact
Regulation Number
876.5990
More FDA Info for this Regulation Number
Classification Product Code
LNS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/12/2013
Decision Date
07/22/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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