| Device Classification Name |
Stocking, Medical Support (For General Medical Purposes)
|
| 510(k) Number |
K944240 |
| Device Name |
SOFT SOCK |
| Applicant |
| Silipos, Inc. |
| 2150 Libertry Dr. |
| Lpo 211 |
|
Niagra Falls,
NY
14304
|
|
| Applicant Contact |
ROBERT L GOULD |
| Correspondent |
| Silipos, Inc. |
| 2150 Libertry Dr. |
| Lpo 211 |
|
Niagra Falls,
NY
14304
|
|
| Correspondent Contact |
ROBERT L GOULD |
| Regulation Number | 880.5780 |
| Classification Product Code |
|
| Date Received | 09/01/1994 |
| Decision Date | 12/27/1994 |
| 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
|
|
|