Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K843487 |
Device Name |
VISITEC OPHTHALMIC FLUID DISTRIB- SET |
Applicant |
VISITEC CO. |
2043 WHITFIELD PARK DR. |
SARASOTA,
FL
33580
|
|
Applicant Contact |
EUGENE H BECKSTEIN |
Correspondent |
VISITEC CO. |
2043 WHITFIELD PARK DR. |
SARASOTA,
FL
33580
|
|
Correspondent Contact |
EUGENE H BECKSTEIN |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 09/06/1984 |
Decision Date | 03/13/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|