Device Classification Name |
Ureteroscope And Accessories, Flexible/Rigid
|
510(k) Number |
K011849 |
Device Name |
MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS |
Applicant |
CIRCON VIDEO |
6500 HOLLISTER AVE. |
SANTA BARBARA,
CA
93117 -3019
|
|
Applicant Contact |
WAYNE B STERNER |
Correspondent |
CIRCON VIDEO |
6500 HOLLISTER AVE. |
SANTA BARBARA,
CA
93117 -3019
|
|
Correspondent Contact |
WAYNE B STERNER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/13/2001 |
Decision Date | 12/10/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|