Device Classification Name |
Cystoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K003988 |
Device Name |
UROSCOPE, ARTES MEDICAL, USA |
Applicant |
ARTES MEDICAL USA, INC. |
4660 LA JOLLA VILLAGE DR. |
CENTER 1, SUITE 825 |
SAN DIEGO,
CA
92122
|
|
Applicant Contact |
WILLIAM KIRKPATRICK |
Correspondent |
ARTES MEDICAL USA, INC. |
4660 LA JOLLA VILLAGE DR. |
CENTER 1, SUITE 825 |
SAN DIEGO,
CA
92122
|
|
Correspondent Contact |
WILLIAM KIRKPATRICK |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/26/2000 |
Decision Date | 09/06/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|