Device Classification Name |
Ureteroscope And Accessories, Flexible/Rigid
|
510(k) Number |
K872282 |
Device Name |
FLEXIBLE URETEROSCOPE |
Applicant |
INTRAMED LABORATORIES, INC. |
11100 ROSELLE ST. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
A SOSNOWSKI |
Correspondent |
INTRAMED LABORATORIES, INC. |
11100 ROSELLE ST. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
A SOSNOWSKI |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/16/1987 |
Decision Date | 09/14/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|