Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Aqua Naina Sterile Saline Solution

K-Number: K193441 · 2020-05-26

ApplicantChemtex USA, Inc.
Decision Date2020-05-26
Product CodeLPN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Aqua Naina Sterile Saline Solution is a medical device manufactured by Chemtex USA, Inc.. It received FDA 510(k) clearance on 2020-05-26 under approval number K193441. The device is classified under product code LPN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aqua Naina Sterile Saline Solution?

Aqua Naina Sterile Saline Solution is a medical device that received FDA 510(k) clearance on 2020-05-26. It is manufactured by Chemtex USA, Inc.. The 510(k) number is K193441.

When was Aqua Naina Sterile Saline Solution approved by the FDA?

Aqua Naina Sterile Saline Solution received FDA 510(k) clearance on 2020-05-26, under approval number K193441.

What company makes Aqua Naina Sterile Saline Solution?

Aqua Naina Sterile Saline Solution is manufactured by Chemtex USA, Inc..

What is the FDA product code for Aqua Naina Sterile Saline Solution?

The FDA product code for Aqua Naina Sterile Saline Solution is LPN.

Related Clinical Trials

NCT07266688 Evaluation of Bactorinol® Nasal Spray in Adult Patients With Vasomotor Rhinitis COMPLETED NCT06264141 Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis COMPLETED NCT07534865 Hyperthermia Combined With Hydrogen Peroxide Microneedle Patch for Viral Warts RECRUITING NCT04559334 Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients SUSPENDED NCT07529444 Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental Implants RECRUITING NCT07321704 Effect of Antiseptic Irrigations With 0.05% Chlorhexidine Gluconate (Irrisept) Versus Normal Saline on Fasciocutaneous Flap-Based Closure of Pilonidal Disease RECRUITING

Other Devices by Chemtex USA, Inc.

K221263Aqua Naina Plus Sterile Saline Solution

Related Devices (Code: LPN)

K161819NNR06 Multi-Purpose SolutionBausch & Lomb, Incorporated K162597Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODiscAlcon Laboratories, Inc. K161622LensGiene Sterile Saline SolutionOptics Laboratory, Inc. K170483Bausch + Lomb Sensitive Eyes Plus Saline SolutionBausch & Lomb, Incorporated K190674REFRESH RELIEVA For CONTACTSAllergan, Inc. K191795AOCup Lens Case with AODiscAlcon Laboratories, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑