Device Classification Name |
Stent, Ureteral
|
510(k) Number |
K850175 |
Device Name |
MENTOR DBL-COIL INDWELL. SILICONE URETERAL STENT S |
Applicant |
MENTOR CORP. |
600 PINE AVE. |
GOLETA,
CA
93117
|
|
Applicant Contact |
GREGORY L JOHNSON |
Correspondent |
MENTOR CORP. |
600 PINE AVE. |
GOLETA,
CA
93117
|
|
Correspondent Contact |
GREGORY L JOHNSON |
Regulation Number | 876.4620
|
Classification Product Code |
|
Date Received | 01/17/1985 |
Decision Date | 03/07/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|