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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K150669
Device Name Neoss TiBase, Neoss CoCr Abutments (Mono and Multi)
Applicant
Neoss, Ltd.
Windsor House Cornwall Rd.
Harrogate,  GB Hg1 2PW
Applicant Contact Karin Darle Olsson
Correspondent
Msquared Associates, Inc.
575 8th Ave.
Suite 1212
New York,  NY  10018
Correspondent Contact CHERITA JAMES
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/16/2015
Decision Date 10/08/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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