Device Classification Name |
Sunglasses (Non-Prescription Including Photosensitive)
|
510(k) Number |
K971384 |
Device Name |
(BRAND NAME) |
Applicant |
LONG IN TIME ENT. CO., LTD. |
NO. 7 ALLEY 500 LN. 942 TAI |
WAN RD., YUNG KANG HSIANG |
TAINAN HSIEN,
TW
|
|
Applicant Contact |
PAUL LEE |
Correspondent |
LONG IN TIME ENT. CO., LTD. |
NO. 7 ALLEY 500 LN. 942 TAI |
WAN RD., YUNG KANG HSIANG |
TAINAN HSIEN,
TW
|
|
Correspondent Contact |
PAUL LEE |
Regulation Number | 886.5850
|
Classification Product Code |
|
Date Received | 04/14/1997 |
Decision Date | 07/01/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|