Device Classification Name |
Sunglasses (Non-Prescription Including Photosensitive)
|
510(k) Number |
K941076 |
Device Name |
SUNGLASSES AND SPORT SUNGLASSES |
Applicant |
20/20 ENT. |
2705-B, NORTH DURFEE AVE. |
EL MONTE,
CA
91732
|
|
Applicant Contact |
SHALLY YUAN |
Correspondent |
20/20 ENT. |
2705-B, NORTH DURFEE AVE. |
EL MONTE,
CA
91732
|
|
Correspondent Contact |
SHALLY YUAN |
Regulation Number | 886.5850
|
Classification Product Code |
|
Date Received | 03/08/1994 |
Decision Date | 04/12/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|