Device Classification Name |
Lithotriptor, Electro-Hydraulic
|
510(k) Number |
K951531 |
Device Name |
SWISS LITHOCLAST LITHOTRIPTER |
Applicant |
ELECTRO MEDICAL SYSTEMS SA |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
JAMES R VEALE |
Correspondent |
ELECTRO MEDICAL SYSTEMS SA |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
JAMES R VEALE |
Regulation Number | 876.4480
|
Classification Product Code |
|
Date Received | 04/03/1995 |
Decision Date | 08/24/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|