Aqua Naina Sterile Saline Solution— 510(k) K193441

Substantially Equivalent

Chemtex USA, Inc.

FDA 510(k) clearance K193441 for Aqua Naina Sterile Saline Solution, Substantially Equivalent on 2020-05-26. Applicant: Chemtex USA, Inc..

Clearance details

Applicant: Chemtex USA, Inc.
Product code: Code LPN
Advisory panel: Ophthalmic
Date received: 2019-12-11
Decision date: 2020-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LPN

product code LPN

Injury: 333
Other: 8
Total: 341

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.