FDA 510(k)

CLEANE / CLEANE POP

K-Number: K111341 · 2012-02-29

Decision Date2012-02-29

Product CodeOZC

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

CLEANE / CLEANE POP is the device name listed in this FDA 510(k) record. The listed applicant is Medicon Co., Ltd.. It received FDA 510(k) clearance on 2012-02-29 under 510(k) number K111341. The device is classified under product code OZC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEANE / CLEANE POP?

CLEANE / CLEANE POP is a medical device that received FDA 510(k) clearance on 2012-02-29. The listed applicant is Medicon Co., Ltd.. The 510(k) number is K111341.

When did CLEANE / CLEANE POP receive FDA 510(k) clearance?

CLEANE / CLEANE POP received FDA 510(k) clearance on 2012-02-29, under 510(k) number K111341.

Who is the listed applicant for CLEANE / CLEANE POP?

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

What is the FDA product code for CLEANE / CLEANE POP?

The FDA product code for CLEANE / CLEANE POP is OZC.

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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.