The following data is part of a premarket notification filed by Chemtex Usa, Inc. with the FDA for Aqua Naina Sterile Saline Solution.
| Device ID | K193441 |
| 510k Number | K193441 |
| Device Name: | Aqua Naina Sterile Saline Solution |
| Classification | Accessories, Soft Lens Products |
| Applicant | Chemtex USA, Inc. 27-29 Dwight Place Fairfield, NJ 07004 -3303 |
| Contact | Haribabu Talasila |
| Correspondent | Thomas Padula Schiff & Company, Inc. 583 Mountain Avenue North Caldwell, NJ 07006 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-11 |
| Decision Date | 2020-05-26 |