| 510(k) Number |
K863733 |
| Device Name |
TOWEL PACK, SURGICAL |
| Applicant |
| East Texas Lighthouse For the Blind |
| 1716 Forest Ave. |
|
Tyler,
TX
75702
|
|
| Applicant Contact |
JON E SAMSILL |
| Correspondent |
| East Texas Lighthouse For the Blind |
| 1716 Forest Ave. |
|
Tyler,
TX
75702
|
|
| Correspondent Contact |
JON E SAMSILL |
| Date Received | 09/23/1986 |
| Decision Date | 10/14/1986 |
| 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
|
|
|