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FDA 510(k)

MENICON UNIQUE PH MULTI-PURPOSE SOLUTION

K-Number: K130805 · 2013-07-03

ApplicantMenicon Co, Ltd.
Decision Date2013-07-03
Product CodeMRC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MENICON UNIQUE PH MULTI-PURPOSE SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Menicon Co, Ltd.. It received FDA 510(k) clearance on 2013-07-03 under 510(k) number K130805. 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 MENICON UNIQUE PH MULTI-PURPOSE SOLUTION?

MENICON UNIQUE PH MULTI-PURPOSE SOLUTION is a medical device that received FDA 510(k) clearance on 2013-07-03. The listed applicant is Menicon Co, Ltd.. The 510(k) number is K130805.

When did MENICON UNIQUE PH MULTI-PURPOSE SOLUTION receive FDA 510(k) clearance?

MENICON UNIQUE PH MULTI-PURPOSE SOLUTION received FDA 510(k) clearance on 2013-07-03, under 510(k) number K130805.

Who is the listed applicant for MENICON UNIQUE PH MULTI-PURPOSE SOLUTION?

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

What is the FDA product code for MENICON UNIQUE PH MULTI-PURPOSE SOLUTION?

The FDA product code for MENICON UNIQUE PH MULTI-PURPOSE SOLUTION is MRC.

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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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