Device Classification Name |
shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
|
510(k) Number |
K896172 |
Device Name |
STRAPPED EYE SHIELD |
Applicant |
EYE GARTER COMPANY, INC. |
8535 WEST BELLFORT |
HOUSTON,
TX
77071
|
|
Applicant Contact |
GOFFMAN, MD |
Correspondent |
EYE GARTER COMPANY, INC. |
8535 WEST BELLFORT |
HOUSTON,
TX
77071
|
|
Correspondent Contact |
GOFFMAN, MD |
Regulation Number | 886.4750
|
Classification Product Code |
|
Date Received | 10/25/1989 |
Decision Date | 11/03/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|