| Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
| 510(k) Number |
K850460 |
| Device Name |
VIGGO SECALON T CATHETER |
| Applicant |
| Viggo Products |
| Ohmeda |
| P.O. Box 7550 |
|
Madison,
WI
53707
|
|
| Applicant Contact |
RAYMOND T RIDDLE |
| Correspondent |
| Viggo Products |
| Ohmeda |
| P.O. Box 7550 |
|
Madison,
WI
53707
|
|
| Correspondent Contact |
RAYMOND T RIDDLE |
| Regulation Number | 880.5200 |
| Classification Product Code |
|
| Date Received | 02/06/1985 |
| Decision Date | 04/11/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|