Device Classification Name |
Lithotriptor, Electro-Hydraulic
|
510(k) Number |
K925396 |
Device Name |
PULSE GUARD ELECTRODE |
Applicant |
NORTHGATE TECHNOLOGIES, INC. |
3930 VENTURA DR. |
ARLINGTON HEIGHTS,
IL
60004
|
|
Applicant Contact |
KENNETH J SIKORA |
Correspondent |
NORTHGATE TECHNOLOGIES, INC. |
3930 VENTURA DR. |
ARLINGTON HEIGHTS,
IL
60004
|
|
Correspondent Contact |
KENNETH J SIKORA |
Regulation Number | 876.4480
|
Classification Product Code |
|
Date Received | 10/26/1992 |
Decision Date | 07/30/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|