Device Classification Name |
shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
|
510(k) Number |
K945351 |
Device Name |
SHIELD, EYE, OPHTHALMIC |
Applicant |
TAIWAN EVA INDUSTRIAL CO., INC. |
P.O. BOX 1445 |
KAOHSIUNG,
TW
|
|
Applicant Contact |
HOLLY LIN |
Correspondent |
TAIWAN EVA INDUSTRIAL CO., INC. |
P.O. BOX 1445 |
KAOHSIUNG,
TW
|
|
Correspondent Contact |
HOLLY LIN |
Regulation Number | 886.4750
|
Classification Product Code |
|
Date Received | 09/14/1994 |
Decision Date | 12/13/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|