| 510(k) Number |
K870905 |
| Device Name |
SURE DROP |
| Applicant |
| Sheldon Eyedrop Support, Inc. |
| 9034 Westheimer Rd., #106 |
|
Houston,
TX
77063
|
|
| Applicant Contact |
SHELDON, M.D. |
| Correspondent |
| Sheldon Eyedrop Support, Inc. |
| 9034 Westheimer Rd., #106 |
|
Houston,
TX
77063
|
|
| Correspondent Contact |
SHELDON, M.D. |
| Date Received | 03/05/1987 |
| Decision Date | 04/24/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Ophthalmic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|