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FDA 510(k)

OPTIMUM WETTING AND REWETTING DROP

K-Number: K001428 · 2000-05-26

ApplicantLobob Laboratories, Inc.
Decision Date2000-05-26
Product CodeMRC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTIMUM WETTING AND REWETTING DROP is the device name listed in this FDA 510(k) record. The listed applicant is Lobob Laboratories, Inc.. It received FDA 510(k) clearance on 2000-05-26 under 510(k) number K001428. 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 OPTIMUM WETTING AND REWETTING DROP?

OPTIMUM WETTING AND REWETTING DROP is a medical device that received FDA 510(k) clearance on 2000-05-26. The listed applicant is Lobob Laboratories, Inc.. The 510(k) number is K001428.

When did OPTIMUM WETTING AND REWETTING DROP receive FDA 510(k) clearance?

OPTIMUM WETTING AND REWETTING DROP received FDA 510(k) clearance on 2000-05-26, under 510(k) number K001428.

Who is the listed applicant for OPTIMUM WETTING AND REWETTING DROP?

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

What is the FDA product code for OPTIMUM WETTING AND REWETTING DROP?

The FDA product code for OPTIMUM WETTING AND REWETTING DROP is MRC.

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Other records listing Lobob Laboratories, 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.

K014162MODIFICATION TO OPTIMUM CLEANING, DISINFECTING ANDK001964OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTIONK990044LOBOB UNIVERSAL CONTACT LENS CLEANER

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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