Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K863957 |
Device Name |
TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR GU |
Applicant |
CATHAID, INC. |
P.O. BOX 161455 |
MIAMI,
FL
33116
|
|
Applicant Contact |
HOWARD F SCOTT |
Correspondent |
CATHAID, INC. |
P.O. BOX 161455 |
MIAMI,
FL
33116
|
|
Correspondent Contact |
HOWARD F SCOTT |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 10/10/1986 |
Decision Date | 10/24/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|