The following data is part of a premarket notification filed by Jeou Jeou Long Industrial Co., Ltd. with the FDA for Sunglasses.
Device ID | K973528 |
510k Number | K973528 |
Device Name: | SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | JEOU JEOU LONG INDUSTRIAL CO., LTD. 7 CHIEH MIN RD., LANE 285 Kaohsiung, TW |
Contact | C K Liu |
Correspondent | C K Liu JEOU JEOU LONG INDUSTRIAL CO., LTD. 7 CHIEH MIN RD., LANE 285 Kaohsiung, TW |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-09-17 |
Decision Date | 1997-12-08 |