Device Classification Name |
Colonoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K884857 |
Device Name |
COLONOSCOPE GUIDING TUBE DEVICE |
Applicant |
MILL-ROSE LABORATORY |
7310 CORPORATE BLVD. |
MENTOR,
OH
44060 -4885
|
|
Applicant Contact |
MARK KOZAK |
Correspondent |
MILL-ROSE LABORATORY |
7310 CORPORATE BLVD. |
MENTOR,
OH
44060 -4885
|
|
Correspondent Contact |
MARK KOZAK |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/21/1988 |
Decision Date | 03/17/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|