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FDA 510(k)

SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL

K-Number: K112743 · 2011-12-16

ApplicantClean Medical Manfacturing Co;Ltd
Decision Date2011-12-16
Product CodeLYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL is the device name listed in this FDA 510(k) record. The listed applicant is Clean Medical Manfacturing Co;Ltd. It received FDA 510(k) clearance on 2011-12-16 under 510(k) number K112743. The device is classified under product code LYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL?

SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL is a medical device that received FDA 510(k) clearance on 2011-12-16. The listed applicant is Clean Medical Manfacturing Co;Ltd. The 510(k) number is K112743.

When did SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL receive FDA 510(k) clearance?

SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL received FDA 510(k) clearance on 2011-12-16, under 510(k) number K112743.

Who is the listed applicant for SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL?

The FDA 510(k) record lists Clean Medical Manfacturing Co;Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL?

The FDA product code for SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL is LYZ.

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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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