Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K953359 |
Device Name |
TRI-STAR UNIVERSAL I/A PHACO PAK |
Applicant |
TRI-STAR OPHTHALMIC |
112 FOREST PT. LN. |
LONGWOOD,
FL
32779
|
|
Applicant Contact |
MIKE ANDERSON |
Correspondent |
TRI-STAR OPHTHALMIC |
112 FOREST PT. LN. |
LONGWOOD,
FL
32779
|
|
Correspondent Contact |
MIKE ANDERSON |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 07/17/1995 |
Decision Date | 10/17/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|