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FDA 510(k)

COVAMESH

K-Number: K130428 · 2013-10-25

ApplicantBiomup S.A.
Decision Date2013-10-25
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COVAMESH is the device name listed in this FDA 510(k) record. The listed applicant is Biomup S.A.. It received FDA 510(k) clearance on 2013-10-25 under 510(k) number K130428. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COVAMESH?

COVAMESH is a medical device that received FDA 510(k) clearance on 2013-10-25. The listed applicant is Biomup S.A.. The 510(k) number is K130428.

When did COVAMESH receive FDA 510(k) clearance?

COVAMESH received FDA 510(k) clearance on 2013-10-25, under 510(k) number K130428.

Who is the listed applicant for COVAMESH?

The FDA 510(k) record lists Biomup S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COVAMESH?

The FDA product code for COVAMESH is FTL.

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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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