Device Classification Name |
Lithotriptor, Electro-Hydraulic
|
510(k) Number |
K931779 |
Device Name |
EHL PULSE GENERATOR |
Applicant |
PSI MEDICAL PRODUCTS, INC. |
240 LONG HILL CROSS RD. |
SHELTON,
CT
06484
|
|
Applicant Contact |
JOHN J SOKOLOWSKI |
Correspondent |
PSI MEDICAL PRODUCTS, INC. |
240 LONG HILL CROSS RD. |
SHELTON,
CT
06484
|
|
Correspondent Contact |
JOHN J SOKOLOWSKI |
Regulation Number | 876.4480
|
Classification Product Code |
|
Date Received | 04/09/1993 |
Decision Date | 02/15/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|