| Device Classification Name |
Frame, Spectacle
|
| 510(k) Number |
K945340 |
| Device Name |
SPECTACLE FRAMES OR EYEGLASS FRAMES |
| Applicant |
| Mi Mun Corp. |
| 1076-1, Pyungri-Dong, Seo-Gu |
|
Daegu,
KR
703013
|
|
| Applicant Contact |
HWI-SUNG LIM |
| Correspondent |
| Mi Mun Corp. |
| 1076-1, Pyungri-Dong, Seo-Gu |
|
Daegu,
KR
703013
|
|
| Correspondent Contact |
HWI-SUNG LIM |
| Regulation Number | 886.5842 |
| Classification Product Code |
|
| Date Received | 11/01/1994 |
| Decision Date | 11/22/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Ophthalmic
|
| 510k Review Panel |
Ophthalmic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|