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FDA 510(k)

OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION

K-Number: K112909 · 2012-04-30

ApplicantBausch & Lomb, Inc.
Decision Date2012-04-30
Product CodeLPN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Inc.. It received FDA 510(k) clearance on 2012-04-30 under 510(k) number K112909. 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 OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION?

OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION is a medical device that received FDA 510(k) clearance on 2012-04-30. The listed applicant is Bausch & Lomb, Inc.. The 510(k) number is K112909.

When did OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION receive FDA 510(k) clearance?

OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION received FDA 510(k) clearance on 2012-04-30, under 510(k) number K112909.

Who is the listed applicant for OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION?

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

What is the FDA product code for OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION?

The FDA product code for OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION is LPN.

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Other records listing Bausch & Lomb, 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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