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 Number | 876.5990
|
Classification Product Code |
|
Date Received | 03/23/2007 |
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
|
Recalls |
CDRH Recalls
|
|
|