| Device Classification Name |
Plug, Punctum
|
| 510(k) Number |
K945906 |
| Device Name |
SILICONE PUNCTAL PLUG |
| Applicant |
| Oasis Medical, Inc. |
| 514 S Vermont Ave. |
|
Glendora,
CA
91741
|
|
| Applicant Contact |
NORMAN DELGADO |
| Correspondent |
| Oasis Medical, Inc. |
| 514 S Vermont Ave. |
|
Glendora,
CA
91741
|
|
| Correspondent Contact |
NORMAN DELGADO |
| Classification Product Code |
|
| Date Received | 12/02/1994 |
| Decision Date | 01/03/1995 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Ophthalmic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|