Device Classification Name |
Lens, Spectacle, Non-Custom (Prescription)
|
510(k) Number |
K852403 |
Device Name |
AURALITE II |
Applicant |
AURA LENS PRODUCTS |
P.O. BOX 763 |
ST. CLOUD,
MN
56302 -0763
|
|
Applicant Contact |
ROBERT N AURELIUS |
Correspondent |
AURA LENS PRODUCTS |
P.O. BOX 763 |
ST. CLOUD,
MN
56302 -0763
|
|
Correspondent Contact |
ROBERT N AURELIUS |
Regulation Number | 886.5844
|
Classification Product Code |
|
Date Received | 06/06/1985 |
Decision Date | 08/20/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|