Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K925254 |
Device Name |
AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38 |
Applicant |
ALLERGAN MEDICAL OPTICS |
KM 4,2 RD. 402 |
ANASCO,
PR
00610
|
|
Applicant Contact |
BARBARA A NIKSCH |
Correspondent |
ALLERGAN MEDICAL OPTICS |
KM 4,2 RD. 402 |
ANASCO,
PR
00610
|
|
Correspondent Contact |
BARBARA A NIKSCH |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 10/19/1992 |
Decision Date | 01/07/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|