Device Classification Name |
accessories, catheter
|
510(k) Number |
K864115 |
Device Name |
TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU |
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 | 878.4200
|
Classification Product Code |
|
Date Received | 10/10/1986 |
Decision Date | 11/07/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|