The following data is part of a premarket notification filed by Fiftytwoways Ltd with the FDA for Contact Lens Case Round Glasses.
| Device ID | K171163 |
| 510k Number | K171163 |
| Device Name: | Contact Lens Case Round Glasses |
| Classification | Case, Contact Lens |
| Applicant | FiftyTwoWays Ltd Unit 4, 7th Floor, Flat B, Grand Ind. Bldg, 159-165 Wo Yi Hop Rd Kwai Chung, HK |
| Contact | Jos Reinders |
| Correspondent | Jos Reinders FiftyTwoWays Ltd Unit 4, 7th Floor, Flat B, Grand Ind. Bldg, 159-165 Wo Yi Hop Rd Kwai Chung, HK |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-20 |
| Decision Date | 2017-06-27 |
| Summary: | summary |