Device Classification Name |
colonoscope and accessories, flexible/rigid
|
510(k) Number |
K032688 |
Device Name |
COLONOSIGHT MODEL 510B |
Applicant |
SIGHTLINE TECHNOLOGIES LTD. |
MATAM - BLDG. 20 |
HAIFA,
IL
31905
|
|
Applicant Contact |
SHARON GOLDFARB-ALBAK |
Correspondent |
SIGHTLINE TECHNOLOGIES LTD. |
MATAM - BLDG. 20 |
HAIFA,
IL
31905
|
|
Correspondent Contact |
SHARON GOLDFARB-ALBAK |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/29/2003 |
Decision Date | 03/05/2004 |
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
|
|
|