The following data is part of a premarket notification filed by E-link Plastic & Metal Industrial Co.,ltd with the FDA for Contact Lens Case.
| Device ID | K171539 |
| 510k Number | K171539 |
| Device Name: | Contact Lens Case |
| Classification | Case, Contact Lens |
| Applicant | E-Link Plastic & Metal Industrial Co.,Ltd No.69-40, Hsing Shuh Rd. Hsing Chung Zone New Taipei, CN 24262 |
| Contact | Marvis Lee |
| Correspondent | Long Yang Shenzhen Hlongmed Biotech Company 1002, 10th Floor, Zhongxing Administrative Building Zhongxing Industrial Zone, Chuangye Road, Nanshan Shenzhen, CN 518054 |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-26 |
| Decision Date | 2017-07-14 |
| Summary: | summary |