Device Classification Name |
device, irrigation, ocular surgery
|
510(k) Number |
K981116 |
Device Name |
SOVEREIGN CATARACT EXTRACTION SYSTEM |
Applicant |
ALLERGAN, INC. |
2525 DUPONT DR. |
P.O. BOX 19534 |
IRVINE,
CA
92623 -9534
|
|
Applicant Contact |
MARCIA S YAROSS, PH,D. |
Correspondent |
ALLERGAN, INC. |
2525 DUPONT DR. |
P.O. BOX 19534 |
IRVINE,
CA
92623 -9534
|
|
Correspondent Contact |
MARCIA S YAROSS, PH,D. |
Regulation Number | 886.4360
|
Classification Product Code |
|
Date Received | 03/27/1998 |
Decision Date | 05/19/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|