Device Classification Name |
Lithotriptor, Electro-Hydraulic
|
510(k) Number |
K914516 |
Device Name |
9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION |
Applicant |
NORTHGATE TECHNOLOGIES, INC. |
3930 VENTURA DR. |
ARLINGTON HEIGHTS,
IL
60004
|
|
Applicant Contact |
SCOTT K GILCHRIST |
Correspondent |
NORTHGATE TECHNOLOGIES, INC. |
3930 VENTURA DR. |
ARLINGTON HEIGHTS,
IL
60004
|
|
Correspondent Contact |
SCOTT K GILCHRIST |
Regulation Number | 876.4480
|
Classification Product Code |
|
Date Received | 10/09/1991 |
Decision Date | 01/07/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|