Device Classification Name |
Anoscope And Accessories
|
510(k) Number |
K011825 |
Device Name |
RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE |
Applicant |
SIGHTLINE TECHNOLOGIES LTD. |
ADVANCED TECHNOLOGY CENTER |
MATAM, HAIFA,
IL
31905
|
|
Applicant Contact |
SIMCHA EDELL |
Correspondent |
SIGHTLINE TECHNOLOGIES LTD. |
ADVANCED TECHNOLOGY CENTER |
MATAM, HAIFA,
IL
31905
|
|
Correspondent Contact |
SIMCHA EDELL |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/11/2001 |
Decision Date | 07/11/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|