Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K863209 |
Device Name |
US PLUS-PAK(R) SURGICAL SYSTEM |
Applicant |
IPAX, INC. |
2109 WEST AMHERST AVE. |
ENGLEWOOD,
CO
80110
|
|
Applicant Contact |
PHILLIP PENNELL |
Correspondent |
IPAX, INC. |
2109 WEST AMHERST AVE. |
ENGLEWOOD,
CO
80110
|
|
Correspondent Contact |
PHILLIP PENNELL |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 08/20/1986 |
Decision Date | 09/08/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|