| Device Classification Name |
Trousers, Anti-Shock
|
| 510(k) Number |
K953763 |
| Device Name |
GLADIATOR ANTISHOCK PANTS |
| Applicant |
| Jobst Institute, Inc. |
| 5825 Carnegie Blvd. |
|
Charlotte,
NC
28209
|
|
| Applicant Contact |
ANGELO R PEREIRA |
| Correspondent |
| Jobst Institute, Inc. |
| 5825 Carnegie Blvd. |
|
Charlotte,
NC
28209
|
|
| Correspondent Contact |
ANGELO R PEREIRA |
| Regulation Number | 870.5800 |
| Classification Product Code |
|
| Date Received | 08/11/1995 |
| Decision Date | 11/28/1995 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|