Device Classification Name |
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
|
510(k) Number |
K102949 |
Device Name |
COLONOSCOPY ASSISTANT |
Applicant |
STI MEDICAL SYSTEMS, LLC |
99-193 AIEA HEIGHTS DRIVE |
AIEA,
HI
96701
|
|
Applicant Contact |
ROLF WOLTERS |
Correspondent |
STI MEDICAL SYSTEMS, LLC |
99-193 AIEA HEIGHTS DRIVE |
AIEA,
HI
96701
|
|
Correspondent Contact |
ROLF WOLTERS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/05/2010 |
Decision Date | 06/15/2011 |
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
|
|
|