Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K984143 |
Device Name |
FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM |
Applicant |
FIBRA SONICS, INC. |
5312 N. ELSTON AVE. |
CHICAGO,
IL
60630
|
|
Applicant Contact |
ROBERT BROHM |
Correspondent |
FIBRA SONICS, INC. |
5312 N. ELSTON AVE. |
CHICAGO,
IL
60630
|
|
Correspondent Contact |
ROBERT BROHM |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 11/18/1998 |
Decision Date | 02/16/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|