| Device Classification Name |
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
|
| 510(k) Number |
K894071 |
| Device Name |
COMFORT SHEER FIRM AND SHEER SUPPORT PANTYHOSE |
| Applicant |
| Sara Lee Corp. |
| 470 Hanes Mill Rd. |
| P.O. Box 2760 |
|
Winston-Salem,
NC
27102
|
|
| Applicant Contact |
CHARLES LACKEY |
| Correspondent |
| Sara Lee Corp. |
| 470 Hanes Mill Rd. |
| P.O. Box 2760 |
|
Winston-Salem,
NC
27102
|
|
| Correspondent Contact |
CHARLES LACKEY |
| Regulation Number | 880.5780 |
| Classification Product Code |
|
| Date Received | 06/08/1989 |
| Decision Date | 10/18/1989 |
| 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
|
|
|