Device Classification Name |
Colonoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K081004 |
Device Name |
PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL |
Applicant |
STRYKER GI |
1420 LAKESIDE PARKWAY, #110 |
FLOWER MOUND,
TX
75028
|
|
Applicant Contact |
TIFFANI ROGERS |
Correspondent |
STRYKER GI |
1420 LAKESIDE PARKWAY, #110 |
FLOWER MOUND,
TX
75028
|
|
Correspondent Contact |
TIFFANI ROGERS |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/08/2008 |
Decision Date | 05/02/2008 |
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
|
|
|