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FDA 510(k) Application Details - K053640
Device Classification Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
More FDA Info for this Device
510(K) Number
K053640
Device Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
Applicant
DIREX SYSTEMS CORP.
437 TURNPIKE ST.
CANTON, MA 02021 US
Other 510(k) Applications for this Company
Contact
LARISA GERSHTEIN
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
12/30/2005
Decision Date
03/01/2006
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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