Device Classification Name |
Colonoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K141598 |
Device Name |
FUSE COLONOSCOPY SYSTEM |
Applicant |
ENDOCHOICE, INC. |
3 HATOCHEN ST., BUSINESS AND INDUSTRIAL PARK (NORTH) |
CAESAREA,
IL
3088900
|
|
Applicant Contact |
TAMAR FUERST |
Correspondent |
ENDOCHOICE, INC. |
3 HATOCHEN ST., BUSINESS AND INDUSTRIAL PARK (NORTH) |
CAESAREA,
IL
3088900
|
|
Correspondent Contact |
TAMAR FUERST |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/13/2014 |
Decision Date | 09/30/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|