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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
Applicant
Neoss Ltd
Windsor House Cornwall Road
Harrogate,  GB Hg1 2PW
Applicant Contact Karin Darle Olsson
Correspondent
M Sqaured Associates, Inc.
575 8th Avenue, Suite 1212
New York,  NY  10018
Correspondent Contact Cherita James
Regulation Number872.3930
Classification Product Code
NPK  
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
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