510(k) Premarket Notification Database
Device Classification Name |
sunglasses (non-prescription including photosensitive)
|
510(k) Number | K941929 |
Device Name | SUNGLASSES |
Applicant |
TOP CHAMP, INC.
|
1453 e. 4th. st. |
los angeles,
CA
90033 |
|
Contact | jerry huang |
Regulation Number | 886.5850 |
Classification Product Code |
|
Date Received | 04/20/1994 |
Decision Date | 08/02/1994 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Ophthalmic
|
Review Advisory Committee |
Ophthalmic
|
Statement/Summary/Purged Status |
Statement only
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
|
|
|