Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K913611 |
Device Name |
COWBOY |
Applicant |
KINETIC CONCEPTS, INC. |
4958 STOUT DR. |
SAN ANTONIO,
TX
78219
|
|
Applicant Contact |
WILLIAM H QUIRK |
Correspondent |
KINETIC CONCEPTS, INC. |
4958 STOUT DR. |
SAN ANTONIO,
TX
78219
|
|
Correspondent Contact |
WILLIAM H QUIRK |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 08/14/1991 |
Decision Date | 01/13/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|