Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K981109 |
Device Name |
QUITETIP |
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 | 03/27/1998 |
Decision Date | 06/09/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|