| Device Classification Name |
Legging, Compression, Non-Inflatable
|
| 510(k) Number |
K871889 |
| Device Name |
COMPRESSION LEGGING DEVICE |
| Applicant |
| A-T Surgical Mfg. Co., Inc. |
| 359 Dwight St. |
|
Holyoke,
MA
01040
|
|
| Applicant Contact |
EUGENE KIREJCZYK |
| Correspondent |
| A-T Surgical Mfg. Co., Inc. |
| 359 Dwight St. |
|
Holyoke,
MA
01040
|
|
| Correspondent Contact |
EUGENE KIREJCZYK |
| Regulation Number | 880.5780 |
| Classification Product Code |
|
| Date Received | 05/15/1987 |
| Decision Date | 08/04/1987 |
| 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
|
|
|