Device Classification Name |
lithotriptor, electro-hydraulic
|
510(k) Number |
K202813 |
Device Name |
URO-TOUCH 9 French Probe |
Applicant |
Northgate Technologies Inc. |
1591 Scottsdale Court |
Elgin,
IL
60123
|
|
Applicant Contact |
Todd Gatto |
Correspondent |
Northgate Technologies Inc. |
1591 Scottsdale Court |
Elgin,
IL
60123
|
|
Correspondent Contact |
Todd Gatto |
Regulation Number | 876.4480
|
Classification Product Code |
|
Date Received | 09/24/2020 |
Decision Date | 06/14/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|