Device Classification Name |
shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
|
510(k) Number |
K880666 |
Device Name |
ULTRAVIOLET LIGHT PROTECTVE EYEWERE |
Applicant |
FREE SUN INTL. AB |
6401 WILBUR AVE. |
RESEDA,
CA
91335
|
|
Applicant Contact |
MILO J SMITH |
Correspondent |
FREE SUN INTL. AB |
6401 WILBUR AVE. |
RESEDA,
CA
91335
|
|
Correspondent Contact |
MILO J SMITH |
Regulation Number | 886.4750
|
Classification Product Code |
|
Date Received | 02/18/1988 |
Decision Date | 06/28/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|