Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K974469 |
Device Name |
MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL |
Applicant |
MENTOR CORP. |
5425 HOLLISTER AVE. |
SANTA BARBARA,
CA
93111
|
|
Applicant Contact |
DONNA A CRAWFORD |
Correspondent |
MENTOR CORP. |
5425 HOLLISTER AVE. |
SANTA BARBARA,
CA
93111
|
|
Correspondent Contact |
DONNA A CRAWFORD |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 11/26/1997 |
Decision Date | 02/24/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|