Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K950881 |
Device Name |
PHACO TIP |
Applicant |
AMERICAN OPTICAL CORP. |
19 HAMMOND |
SUITE 505 |
IRVINE,
CA
92718
|
|
Applicant Contact |
GLENN A DUNKI-JACOBS |
Correspondent |
AMERICAN OPTICAL CORP. |
19 HAMMOND |
SUITE 505 |
IRVINE,
CA
92718
|
|
Correspondent Contact |
GLENN A DUNKI-JACOBS |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 02/27/1995 |
Decision Date | 09/06/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|