Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 the device name listed in this FDA 510(k) record. The listed applicant is Chemtex USA, Inc.. It received FDA 510(k) clearance on 2020-05-26 under 510(k) 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. The listed applicant is Chemtex USA, Inc.. The 510(k) number is K193441.

When did Aqua Naina Sterile Saline Solution receive FDA 510(k) clearance?

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

Who is the listed applicant for Aqua Naina Sterile Saline Solution?

The FDA 510(k) record lists Chemtex USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06339203Wound Irrigation With Saline Versus Hypodilute-chlorhexidine After Cesarean Section (WISHES Study)RECRUITINGNCT07791953Effect of an Intraoperative Polynucleotide Injection on Scar Quality After Thyroidectomy and ParathyroidectomyNOT_YET_RECRUITING

Other records listing Chemtex USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221263Aqua Naina Plus Sterile Saline Solution

Related Devices (Code: LPN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253795MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd.K222541Bausch + Lomb Preservative Free Lubricating and Rewetting DropsBausch & Lomb, IncorporatedK221263Aqua Naina Plus Sterile Saline SolutionChemtex USA, Inc.K202932ABT12 multi-purpose solutionBausch & Lomb, IncorporatedK210051OTE MPS 045 Multi-purpose Lens Care SolutionOte North America, LLCK200747PuriLens Plus Preservative Free SalineThe Lifestyle Company, 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.

↑