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FDA 510(k)

Boston One Step Liquid Enzymatic Cleaner

K-Number: K200416 · 2020-09-23

ApplicantBausch & Lomb, Incorporated
Decision Date2020-09-23
Product CodeMRC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Boston One Step Liquid Enzymatic Cleaner is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Incorporated. It received FDA 510(k) clearance on 2020-09-23 under 510(k) number K200416. The device is classified under product code MRC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Boston One Step Liquid Enzymatic Cleaner?

Boston One Step Liquid Enzymatic Cleaner is a medical device that received FDA 510(k) clearance on 2020-09-23. The listed applicant is Bausch & Lomb, Incorporated. The 510(k) number is K200416.

When did Boston One Step Liquid Enzymatic Cleaner receive FDA 510(k) clearance?

Boston One Step Liquid Enzymatic Cleaner received FDA 510(k) clearance on 2020-09-23, under 510(k) number K200416.

Who is the listed applicant for Boston One Step Liquid Enzymatic Cleaner?

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

What is the FDA product code for Boston One Step Liquid Enzymatic Cleaner?

The FDA product code for Boston One Step Liquid Enzymatic Cleaner is MRC.

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Other records listing Bausch & Lomb, Incorporated as applicant

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Related Devices (Code: MRC)

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.

K251876cleadew GP hydra oneOphtecs CorporationK201069VibrantVue Scleral SalineDry Eye Innovations, LLCK182984MaxiTears Contacts PFOmnivision AGK181566NutrifillContamac, Ltd.K181627Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic CleanerBausch & Lomb, IncorporatedK180319Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning SolutionBausch and Lomb, Incorporated

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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