Device Classification Name |
Stretcher, Hand-Carried
|
510(k) Number |
K896179 |
Device Name |
SKED FLOTATION SYSTEM |
Applicant |
SKEDCO, INC. |
16420 S.W. 72ND AVE. |
P.O. BOX 230487 |
PORTLAND,
OR
97224
|
|
Applicant Contact |
DOUGLAS W BENNETT |
Correspondent |
SKEDCO, INC. |
16420 S.W. 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
|
|
|