Device Classification Name |
Colonoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K063654 |
Device Name |
ENDOGUIDE |
Applicant |
KMS MEDICAL LLC |
7290 SW 42ND STREET |
MIAMI,
FL
33155
|
|
Applicant Contact |
MARIO ARBESU |
Correspondent |
KMS MEDICAL LLC |
7290 SW 42ND STREET |
MIAMI,
FL
33155
|
|
Correspondent Contact |
MARIO ARBESU |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/08/2006 |
Decision Date | 01/31/2007 |
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
|
|
|