Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K914229 |
Device Name |
PHACO TIP |
Applicant |
TRI-STAR OPHTHALMIC |
P.O. BOX 175 |
8105 NEBO HILLS RD. |
LIBERTY,
MO
64068
|
|
Applicant Contact |
THOMAS M REYNOLDS |
Correspondent |
TRI-STAR OPHTHALMIC |
P.O. BOX 175 |
8105 NEBO HILLS RD. |
LIBERTY,
MO
64068
|
|
Correspondent Contact |
THOMAS M REYNOLDS |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 09/20/1991 |
Decision Date | 12/27/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|