The following data is part of a premarket notification filed by Danyang Chanxin Glasses Cases Factory with the FDA for Contact Lens Case (multiple Brand Name).
| Device ID | K160005 |
| 510k Number | K160005 |
| Device Name: | Contact Lens Case (multiple Brand Name) |
| Classification | Case, Contact Lens |
| Applicant | DANYANG CHANXIN GLASSES CASES FACTORY HUADIAN CHUANGYE PARK, DANGUI ROAD, DEVELOPING ZONE Danyang City, CN 212300 |
| Contact | Lemon Chen |
| Correspondent | Mike Gu Osmunda Medical Device Service Group Level 7, Jin Gui Business Center, 982 Cunyun Road, Baiyun District Guangzhou, CN 510420 |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-04 |
| Decision Date | 2016-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974223470046 | K160005 | 000 |
| 06974223470039 | K160005 | 000 |
| 06974223470022 | K160005 | 000 |
| 06974223470015 | K160005 | 000 |
| 06970285515671 | K160005 | 000 |
| 06970285515794 | K160005 | 000 |