Device Classification Name |
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
|
510(k) Number |
K161204 |
Device Name |
ENDOCAM Flex HD Camera System 5521 |
Applicant |
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION |
353 CORPORATE WOODS PARKWAY |
VERNON HILL,
IL
60061
|
|
Applicant Contact |
MIKE LOITERMAN |
Correspondent |
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION |
353 CORPORATE WOODS PARKWAY |
VERNON HILL,
IL
60061
|
|
Correspondent Contact |
MIKE LOITERMAN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/28/2016 |
Decision Date | 01/11/2017 |
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
|