The following data is part of a premarket notification filed by Chemtex Usa Inc. with the FDA for Aqua Naina Plus Sterile Saline Solution.
| Device ID | K221263 |
| 510k Number | K221263 |
| Device Name: | Aqua Naina Plus Sterile Saline Solution |
| Classification | Accessories, Soft Lens Products |
| Applicant | Chemtex USA Inc. 27-29 Dwight Place Fairfield, NJ 07004 -3303 |
| Contact | Haribabu Talasila |
| Correspondent | Bret Andre EyeReg Consulting, Inc. 6119 Canter Lane West Linn, OR 97068 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-02 |
| Decision Date | 2022-10-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860005853410 | K221263 | 000 |