FDA 510(k)

MESO TENDON MATRIX

K-Number: K133169 · 2013-12-20

ApplicantKensey Nash Corporation Dba Dsm Biomedical

Decision Date2013-12-20

Product CodeOWY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MESO TENDON MATRIX 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 2013-12-20 under 510(k) number K133169. The device is classified under product code OWY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MESO TENDON MATRIX?

MESO TENDON MATRIX is a medical device that received FDA 510(k) clearance on 2013-12-20. The listed applicant is Kensey Nash Corporation Dba Dsm Biomedical. The 510(k) number is K133169.

When did MESO TENDON MATRIX receive FDA 510(k) clearance?

MESO TENDON MATRIX received FDA 510(k) clearance on 2013-12-20, under 510(k) number K133169.

Who is the listed applicant for MESO TENDON MATRIX?

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 TENDON MATRIX?

The FDA product code for MESO TENDON MATRIX is OWY.

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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.