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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name barrier, synthetic, intraoral
510(k) Number K143327
Device Name Neoss Ti Reinforced Membrane
Neoss Ltd
Windsor House Cornwall Road
Harrogate,  GB Hg1 2PW
Applicant Contact Karin Darle Olsson
M Sqaured Associates, Inc.
575 8th Avenue, Suite 1212
New York,  NY  10018
Correspondent Contact Cherita James
Regulation Number872.3930
Classification Product Code
Date Received11/20/2014
Decision Date 04/13/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No