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FDA 510(k)

EYE-CEPT REWETTING DROPS

K-Number: K041008 · 2005-07-01

ApplicantOptics Laboratory, Inc.
Decision Date2005-07-01
Product CodeLPN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EYE-CEPT REWETTING DROPS is the device name listed in this FDA 510(k) record. The listed applicant is Optics Laboratory, Inc.. It received FDA 510(k) clearance on 2005-07-01 under 510(k) number K041008. 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 EYE-CEPT REWETTING DROPS?

EYE-CEPT REWETTING DROPS is a medical device that received FDA 510(k) clearance on 2005-07-01. The listed applicant is Optics Laboratory, Inc.. The 510(k) number is K041008.

When did EYE-CEPT REWETTING DROPS receive FDA 510(k) clearance?

EYE-CEPT REWETTING DROPS received FDA 510(k) clearance on 2005-07-01, under 510(k) number K041008.

Who is the listed applicant for EYE-CEPT REWETTING DROPS?

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

What is the FDA product code for EYE-CEPT REWETTING DROPS?

The FDA product code for EYE-CEPT REWETTING DROPS is LPN.

Related Clinical Trials

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Other records listing Optics Laboratory, 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.

K161622LensGiene Sterile Saline SolutionK110221EYE-CEPT 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, LLCK193441Aqua Naina Sterile Saline SolutionChemtex USA, 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.

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