ACCELL EVO3 (FORMERLY ACCELL A2I)— 510(k) K103742

Name: FDA 510(k) clearance K103742
Creator: U.S. Food and Drug Administration
Published: 2011-03-17

Substantially Equivalent

Integra Life Sciences

FDA 510(k) clearance K103742 for ACCELL EVO3 (FORMERLY ACCELL A2I), Substantially Equivalent on 2011-03-17. Applicant: Integra Life Sciences. Device class: 2.

Clearance details

Applicant: Integra Life Sciences
Product code: Code MBP
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2010-12-23
Decision date: 2011-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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