Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K972252 |
Device Name |
VISTA UNIVERSAL HANDPIECE |
Applicant |
ODYSSEY TECHNOLOGIES, INC. |
9327 BLACKLEY ST. |
TEMPLE CITY,
CA
91780
|
|
Applicant Contact |
GLENN A DUNKI-JACOBS |
Correspondent |
ODYSSEY TECHNOLOGIES, INC. |
9327 BLACKLEY ST. |
TEMPLE CITY,
CA
91780
|
|
Correspondent Contact |
GLENN A DUNKI-JACOBS |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 06/16/1997 |
Decision Date | 07/29/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|