Device Classification Name |
shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
|
510(k) Number |
K896681 |
Device Name |
SOFT CORNEAL LIGHT SHIELD |
Applicant |
VISITEC CO. |
7575 COMMERCE COURT |
SARASOTA,
FL
34243 -3218
|
|
Applicant Contact |
LIAQUAT ALLARAKHIA |
Correspondent |
VISITEC CO. |
7575 COMMERCE COURT |
SARASOTA,
FL
34243 -3218
|
|
Correspondent Contact |
LIAQUAT ALLARAKHIA |
Regulation Number | 886.4750
|
Classification Product Code |
|
Date Received | 11/27/1989 |
Decision Date | 01/11/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|