Device Classification Name |
lithotriptor, electro-hydraulic
|
510(k) Number |
K903337 |
Device Name |
1.9 FRENCH LITHOTRIPTER ELECTRODE |
Applicant |
NORTHGATE RESEARCH, INC. |
3930 VENTURA DR. |
SUITE 400 |
ARLINGTON HEIGHTS,
IL
60004
|
|
Applicant Contact |
SHERRI S GALLAGHER |
Correspondent |
NORTHGATE RESEARCH, INC. |
3930 VENTURA DR. |
SUITE 400 |
ARLINGTON HEIGHTS,
IL
60004
|
|
Correspondent Contact |
SHERRI S GALLAGHER |
Regulation Number | 876.4480
|
Classification Product Code |
|
Date Received | 07/25/1990 |
Decision Date | 11/16/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|