| 510(k) Number |
K862731 |
| Device Name |
STA-SOF BREAST COMPRESSOR-CLAMP |
| Applicant |
| Sta-Sof, Inc. |
| 10571 Wyton Rd. |
|
Los Angeles,
CA
90024
|
|
| Applicant Contact |
VALERIE WHEELER-REID |
| Correspondent |
| Sta-Sof, Inc. |
| 10571 Wyton Rd. |
|
Los Angeles,
CA
90024
|
|
| Correspondent Contact |
VALERIE WHEELER-REID |
| Date Received | 07/18/1986 |
| Decision Date | 08/01/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|