Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K971795 |
Device Name |
AUTOMATED CHAMBER MAINTENANCE MODULE |
Applicant |
PARADIGM MEDICAL INDUSTRIES, INC. |
1772 WEST 2300 SOUTH |
SALT LAKE CITY,
UT
84119
|
|
Applicant Contact |
RICHARD DIRKSON |
Correspondent |
PARADIGM MEDICAL INDUSTRIES, INC. |
1772 WEST 2300 SOUTH |
SALT LAKE CITY,
UT
84119
|
|
Correspondent Contact |
RICHARD DIRKSON |
Regulation Number | 886.4670 |
Classification Product Code |
|
Date Received | 05/15/1997 |
Decision Date | 07/14/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|