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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Extracorporeal Shock-Wave, Urological
510(k) Number K070799
Device Name MODULARIS VARIOSTAR
Applicant
SIEMENS MEDICAL SOLUTIONS USA INC.
51 VALLEY STREAM PARKWAY
MS E50
MALVERN,  PA  19355
Applicant Contact KIM RENDON
Correspondent
SIEMENS MEDICAL SOLUTIONS USA INC.
51 VALLEY STREAM PARKWAY
MS E50
MALVERN,  PA  19355
Correspondent Contact KIM RENDON
Regulation Number876.5990
Classification Product Code
LNS  
Date Received03/23/2007
Decision Date 11/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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