Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K902798 |
Device Name |
AUTOMATED HYDROSONICS(TM) |
Applicant |
ALCON SURGICAL, INC. |
17701 COWAN AVE. |
IRVINE,
CA
92713
|
|
Applicant Contact |
DAVID KRAPF |
Correspondent |
ALCON SURGICAL, INC. |
17701 COWAN AVE. |
IRVINE,
CA
92713
|
|
Correspondent Contact |
DAVID KRAPF |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 06/27/1990 |
Decision Date | 08/28/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|