| Device Classification Name |
Stretcher, Hand-Carried
|
| 510(k) Number |
K896179 |
| Device Name |
SKED FLOTATION SYSTEM |
| Applicant |
| Skedco, Inc. |
| 16420 SW 72nd Ave. |
| P.O. Box 230487 |
|
Portland,
OR
97224
|
|
| Applicant Contact |
DOUGLAS W BENNETT |
| Correspondent |
| Skedco, Inc. |
| 16420 SW 72nd Ave. |
| P.O. Box 230487 |
|
Portland,
OR
97224
|
|
| Correspondent Contact |
DOUGLAS W BENNETT |
| Regulation Number | 880.6900 |
| Classification Product Code |
|
| Date Received | 10/25/1989 |
| Decision Date | 01/11/1990 |
| 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
|
|
|