Device Classification Name |
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
|
510(k) Number |
K881135 |
Device Name |
COOL EYE(TM) EYE PROTECTOR |
Applicant |
COOL EYES, INC. |
P.O. BOX 1244 |
HARROW, ONTARIO,
CA
NOR 1GO
|
|
Applicant Contact |
ANNE MILLER |
Correspondent |
COOL EYES, INC. |
P.O. BOX 1244 |
HARROW, ONTARIO,
CA
NOR 1GO
|
|
Correspondent Contact |
ANNE MILLER |
Regulation Number | 886.4750
|
Classification Product Code |
|
Date Received | 03/16/1988 |
Decision Date | 07/08/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|