Device Classification Name |
endoscopic access overtube, gastroenterology-urology
|
510(k) Number |
K201815 |
Device Name |
Dornier MAGELLAN Ureteral Access Sheath |
Applicant |
Dornier MedTech America Inc |
1155 Roberts Blvd, Suite 100 |
Kennesaw,
GA
30144
|
|
Applicant Contact |
John Hoffer |
Correspondent |
Dornier MedTech America Inc |
1155 Roberts Blvd, Suite 100 |
Kennesaw,
GA
30144
|
|
Correspondent Contact |
John Hoffer |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/01/2020 |
Decision Date | 11/20/2020 |
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
|
|
|