Device Classification Name |
shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
|
510(k) Number |
K875107 |
Device Name |
HEALTH CARE EYE PROTECTION |
Applicant |
SURGIKOS, INC. |
P.O. BOX 130 |
ARLINGTON,
TX
76010
|
|
Applicant Contact |
WALTER J MCQUADE |
Correspondent |
SURGIKOS, INC. |
P.O. BOX 130 |
ARLINGTON,
TX
76010
|
|
Correspondent Contact |
WALTER J MCQUADE |
Regulation Number | 886.4750
|
Classification Product Code |
|
Date Received | 12/14/1987 |
Decision Date | 03/21/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|