Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K844373 |
Device Name |
O.M.S. ULTRA-PHACO |
Applicant |
OPTICAL MICRO SYSTEMS, INC. |
8 ELECTRONICS AVE. |
DANVERS,
MA
01923
|
|
Applicant Contact |
GERALD A CLAY |
Correspondent |
OPTICAL MICRO SYSTEMS, INC. |
8 ELECTRONICS AVE. |
DANVERS,
MA
01923
|
|
Correspondent Contact |
GERALD A CLAY |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 11/13/1984 |
Decision Date | 12/19/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|