Device Classification Name |
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
|
510(k) Number |
K840414 |
Device Name |
COLOR OPTIC CORNEAL EYE SHIELD |
Applicant |
DIVERSATIONS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
DIVERSATIONS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.4750
|
Classification Product Code |
|
Date Received | 01/31/1984 |
Decision Date | 08/15/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|