DSM Biomedical Porcine Pericardium Dental Membrane— 510(k) K160474

Name: FDA 510(k) clearance K160474
Creator: U.S. Food and Drug Administration
Published: 2016-06-07

Substantially Equivalent

Kensey Nash Corporation Dba Dsm Biomedical

FDA 510(k) clearance K160474 for DSM Biomedical Porcine Pericardium Dental Membrane, Substantially Equivalent on 2016-06-07. Applicant: Kensey Nash Corporation Dba Dsm Biomedical. Device class: 2.

Clearance details

Applicant: Kensey Nash Corporation Dba Dsm Biomedical
Product code: Code NPL
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2016-02-19
Decision date: 2016-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Exton, PA, US

Download summary PDF View on FDA.gov ↗

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