The following data is part of a premarket notification filed by P L Overseas Limited with the FDA for Contact Lens Case, Model: A-1, B-1.
| Device ID | K172925 |
| 510k Number | K172925 |
| Device Name: | Contact Lens Case, Model: A-1, B-1 |
| Classification | Case, Contact Lens |
| Applicant | P L Overseas Limited Rm. A 4/F Alexandra Indl. Bldg. Blk.A 1064-1066 Tung Chau West St. Cheung Sha Wan, HK |
| Contact | Maggie Li |
| Correspondent | Rain Yip Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center Guimiao Road Shenzhen, CN 518000 |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-25 |
| Decision Date | 2017-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971531016539 | K172925 | 000 |
| 06971531016393 | K172925 | 000 |
| 06971531013712 | K172925 | 000 |
| 06971531013644 | K172925 | 000 |
| 06976832583735 | K172925 | 000 |
| 06976832583728 | K172925 | 000 |