Device Classification Name |
Lens, Spectacle, Non-Custom (Prescription)
|
510(k) Number |
K790215 |
Device Name |
LENS, POLYCORE |
Applicant |
POLYCORE OPTICAL PTE LTD. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
POLYCORE OPTICAL PTE LTD. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.5844
|
Classification Product Code |
|
Date Received | 01/30/1979 |
Decision Date | 02/26/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|