Device Classification Name |
stent, ureteral
|
510(k) Number |
K852389 |
Device Name |
URETERAL STENT |
Applicant |
AMERICAN MEDICAL SYSTEMS, INC. |
11001 BREN RD. EAST |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
MARK E MCINTYRE |
Correspondent |
AMERICAN MEDICAL SYSTEMS, INC. |
11001 BREN RD. EAST |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
MARK E MCINTYRE |
Regulation Number | 876.4620
|
Classification Product Code |
|
Date Received | 06/05/1985 |
Decision Date | 09/05/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|