Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K133599 |
Device Name |
CORGRIP |
Applicant |
CORPAK MEDSYSTEMS |
1001 ASBURY DR |
BUFFALO GROVE,
IL
60089 -0000
|
|
Applicant Contact |
STEPHANIE WASIELEWSKI |
Correspondent |
CORPAK MEDSYSTEMS |
1001 ASBURY DR |
BUFFALO GROVE,
IL
60089 -0000
|
|
Correspondent Contact |
STEPHANIE WASIELEWSKI |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 11/25/2013 |
Decision Date | 03/26/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|