Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K950798 |
Device Name |
POSTERIOR CAPSULE SHIELD |
Applicant |
OASIS MEDICAL, INC. |
514 S. VERMONT AVE. |
GLENDORA,
CA
91741
|
|
Applicant Contact |
JAMES CHRISTENSEN |
Correspondent |
OASIS MEDICAL, INC. |
514 S. VERMONT AVE. |
GLENDORA,
CA
91741
|
|
Correspondent Contact |
JAMES CHRISTENSEN |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 02/21/1995 |
Decision Date | 05/22/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|