Device Classification Name |
catheter, malecot
|
510(k) Number |
K140085 |
Device Name |
UNIVERSA PERCULTANEOUS DRAINAGE CATHETER |
Applicant |
COOK INCORPORATED |
750 DANIELS WAY |
BLOOMINGTON,
IN
47404
|
|
Applicant Contact |
ELYSIA EASTON |
Correspondent |
COOK INCORPORATED |
750 DANIELS WAY |
BLOOMINGTON,
IN
47404
|
|
Correspondent Contact |
ELYSIA EASTON |
Regulation Number | 876.5090
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/13/2014 |
Decision Date | 11/18/2014 |
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
|
|
|