MESO TENDON MATRIX— 510(k) K133169

Name: FDA 510(k) clearance K133169
Creator: U.S. Food and Drug Administration
Published: 2013-12-20

Substantially Equivalent

Kensey Nash Corporation Dba Dsm Biomedical

FDA 510(k) clearance K133169 for MESO TENDON MATRIX, Substantially Equivalent on 2013-12-20. Applicant: Kensey Nash Corporation Dba Dsm Biomedical. Device class: 2.

Clearance details

Applicant: Kensey Nash Corporation Dba Dsm Biomedical
Product code: Code OWY
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2013-10-17
Decision date: 2013-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Exton, PA, US

Download summary PDF View on FDA.gov ↗

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