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FDA 510(k)

REFRESH OPTIVE LENS COMFORT REWETTING DROPS

K-Number: K083812 · 2009-07-09

ApplicantAllergan, Inc.
Decision Date2009-07-09
Product CodeLPN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

REFRESH OPTIVE LENS COMFORT REWETTING DROPS is the device name listed in this FDA 510(k) record. The listed applicant is Allergan, Inc.. It received FDA 510(k) clearance on 2009-07-09 under 510(k) number K083812. 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 REFRESH OPTIVE LENS COMFORT REWETTING DROPS?

REFRESH OPTIVE LENS COMFORT REWETTING DROPS is a medical device that received FDA 510(k) clearance on 2009-07-09. The listed applicant is Allergan, Inc.. The 510(k) number is K083812.

When did REFRESH OPTIVE LENS COMFORT REWETTING DROPS receive FDA 510(k) clearance?

REFRESH OPTIVE LENS COMFORT REWETTING DROPS received FDA 510(k) clearance on 2009-07-09, under 510(k) number K083812.

Who is the listed applicant for REFRESH OPTIVE LENS COMFORT REWETTING DROPS?

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

What is the FDA product code for REFRESH OPTIVE LENS COMFORT REWETTING DROPS?

The FDA product code for REFRESH OPTIVE LENS COMFORT REWETTING DROPS is LPN.

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Other records listing Allergan, Inc. as applicant

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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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