Device Classification Name |
cystoscope and accessories, flexible/rigid
|
510(k) Number |
K060899 |
Device Name |
FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE |
Applicant |
SCHOELLY IMAGING, INC. |
173 GROVE STREET |
WORCESTER,
MA
01605
|
|
Applicant Contact |
BONI S BONNEVILLE |
Correspondent |
SCHOELLY IMAGING, INC. |
173 GROVE STREET |
WORCESTER,
MA
01605
|
|
Correspondent Contact |
BONI S BONNEVILLE |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/03/2006 |
Decision Date | 03/02/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|