Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K962402 |
Device Name |
AMO PRESTIGE DAY PACK (ALLERGAN, INC.) |
Applicant |
ALLERGAN, INC. |
2525 DUPONT DR. |
IRVINE,
CA
92612
|
|
Applicant Contact |
MONIQUE M HEYNINCK |
Correspondent |
ALLERGAN, INC. |
2525 DUPONT DR. |
IRVINE,
CA
92612
|
|
Correspondent Contact |
MONIQUE M HEYNINCK |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 06/21/1996 |
Decision Date | 09/19/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|