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FDA 510(k)

Bausch + Lomb PreVue Inserter for enVista Preloaded

K-Number: K192005 · 2019-10-04

ApplicantBausch & Lomb, Inc.
Decision Date2019-10-04
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Bausch + Lomb PreVue Inserter for enVista Preloaded is a medical device manufactured by Bausch & Lomb, Inc.. It received FDA 510(k) clearance on 2019-10-04 under approval number K192005. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bausch + Lomb PreVue Inserter for enVista Preloaded?

Bausch + Lomb PreVue Inserter for enVista Preloaded is a medical device that received FDA 510(k) clearance on 2019-10-04. It is manufactured by Bausch & Lomb, Inc.. The 510(k) number is K192005.

When was Bausch + Lomb PreVue Inserter for enVista Preloaded approved by the FDA?

Bausch + Lomb PreVue Inserter for enVista Preloaded received FDA 510(k) clearance on 2019-10-04, under approval number K192005.

What company makes Bausch + Lomb PreVue Inserter for enVista Preloaded?

Bausch + Lomb PreVue Inserter for enVista Preloaded is manufactured by Bausch & Lomb, Inc..

What is the FDA product code for Bausch + Lomb PreVue Inserter for enVista Preloaded?

The FDA product code for Bausch + Lomb PreVue Inserter for enVista Preloaded is MSS.

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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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