Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K933627 |
Device Name |
PHACOFRAGMENTOR TIP |
Applicant |
M. IMONTI AND ASSOCIATES INC., |
25707 COMPASS WAY |
SAN JUAN CAPISTRANO,
CA
92675
|
|
Correspondent |
M. IMONTI AND ASSOCIATES INC., |
25707 COMPASS WAY |
SAN JUAN CAPISTRANO,
CA
92675
|
|
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 07/27/1993 |
Decision Date | 01/25/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|