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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name table, cystometric, electric
510(k) Number K033335
Device Name LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MALVERN,  PA  19355 -1406
Applicant Contact DEBBIE PEACOCK
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 VALLEY STREAM PKWY.
MALVERN,  PA  19355 -1406
Correspondent Contact DEBBIE PEACOCK
Regulation Number876.4890
Classification Product Code
MMZ  
Date Received10/16/2003
Decision Date 11/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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