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FDA 510(k) Application Details - K032958
Device Classification Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
More FDA Info for this Device
510(K) Number
K032958
Device Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
Applicant
UNITED MEDICAL SYSTEMS, INC.
555 THIRTEENTH STREET, NW
WASHINGTON, DC 20004-1109 US
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Contact
JEFFREY K SHAPIRO
Other 510(k) Applications for this Contact
Regulation Number
876.5990
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Classification Product Code
LNS
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More FDA Info for this Product Code
Date Received
09/22/2003
Decision Date
02/17/2004
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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