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FDA 510(k)

MESO BILAYER SURGICAL MESH

K-Number: K132025 · 2013-10-30

ApplicantKensey Nash Corporation Dba Dsm Biomedical
Decision Date2013-10-30
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MESO BILAYER SURGICAL MESH is the device name listed in this FDA 510(k) record. The listed applicant is Kensey Nash Corporation Dba Dsm Biomedical. It received FDA 510(k) clearance on 2013-10-30 under 510(k) number K132025. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MESO BILAYER SURGICAL MESH?

MESO BILAYER SURGICAL MESH is a medical device that received FDA 510(k) clearance on 2013-10-30. The listed applicant is Kensey Nash Corporation Dba Dsm Biomedical. The 510(k) number is K132025.

When did MESO BILAYER SURGICAL MESH receive FDA 510(k) clearance?

MESO BILAYER SURGICAL MESH received FDA 510(k) clearance on 2013-10-30, under 510(k) number K132025.

Who is the listed applicant for MESO BILAYER SURGICAL MESH?

The FDA 510(k) record lists Kensey Nash Corporation Dba Dsm Biomedical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MESO BILAYER SURGICAL MESH?

The FDA product code for MESO BILAYER SURGICAL MESH is FTM.

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Other records listing Kensey Nash Corporation Dba Dsm Biomedical as applicant

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Related Devices (Code: FTM)

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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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