| Device Classification Name |
Stripper, Vein, External
|
| 510(k) Number |
K904507 |
| Device Name |
PILLING BRUSH VALVULOTOME |
| Applicant |
| Pilling Co. |
| 420 Delaware Dr. |
|
Fort Washington,
PA
19034
|
|
| Applicant Contact |
SHERRY KRIDER |
| Correspondent |
| Pilling Co. |
| 420 Delaware Dr. |
|
Fort Washington,
PA
19034
|
|
| Correspondent Contact |
SHERRY KRIDER |
| Regulation Number | 870.4885 |
| Classification Product Code |
|
| Date Received | 10/02/1990 |
| Decision Date | 03/01/1991 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|