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FDA 510(k) Application Details - K130729
Device Classification Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
More FDA Info for this Device
510(K) Number
K130729
Device Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
Applicant
DORNIER MEDTECH SYSTEMS
1155 ROBERTS BLVD
KENNESAW, GA 30144 US
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Contact
JOHN HOFFER
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
03/18/2013
Decision Date
05/14/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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