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FDA 510(k) Application Details - K012785
Device Classification Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
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510(K) Number
K012785
Device Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
Applicant
HEALTH TRONICS SURGICAL SERVICES, INC.
1841 WEST OAK PARKWAY, SUITE A
MARIETTA, GA 30062 US
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PETER WEIMAN
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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
08/20/2001
Decision Date
11/16/2001
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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