Device Classification Name |
Lens, Spectacle, Non-Custom (Prescription)
|
510(k) Number |
K861960 |
Device Name |
ZIMLITE LENS |
Applicant |
ASAHI OPTICAL CO. C/O ROSATI ASSOCIATES, P.C. |
3-23. 5-CHOME HINODE. |
FUKUI-CITY 910 |
JAPAN,
JP
|
|
Applicant Contact |
TEKEUCHI |
Correspondent |
ASAHI OPTICAL CO. C/O ROSATI ASSOCIATES, P.C. |
3-23. 5-CHOME HINODE. |
FUKUI-CITY 910 |
JAPAN,
JP
|
|
Correspondent Contact |
TEKEUCHI |
Regulation Number | 886.5844
|
Classification Product Code |
|
Date Received | 05/20/1986 |
Decision Date | 06/09/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|