Device Classification Name |
Lithotriptor, Extracorporeal Shock-Wave, Urological
|
510(k) Number |
K121656 |
Device Name |
GEMINI LITHOTRIPTER |
Applicant |
DORNIER MEDTECH AMERICA, INC. |
1155 ROBERTS BLVD. |
KENNESAW,
GA
30144
|
|
Applicant Contact |
JOHN HOFFER |
Correspondent |
DORNIER MEDTECH AMERICA, INC. |
1155 ROBERTS BLVD. |
KENNESAW,
GA
30144
|
|
Correspondent Contact |
JOHN HOFFER |
Regulation Number | 876.5990
|
Classification Product Code |
|
Date Received | 06/05/2012 |
Decision Date | 09/24/2012 |
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
|
|
|