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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 K081851
Device Name NEOSS ACCESS ABUTMENTS
Applicant
NEOSS, LTD.
WINDSOR HOUSE, CORNWALL RD.
HARROGATE, YORKSHIRE,  GB HG1 2PW
Applicant Contact FREDRIK ENGMAN
Correspondent
NEOSS, LTD.
WINDSOR HOUSE, CORNWALL RD.
HARROGATE, YORKSHIRE,  GB HG1 2PW
Correspondent Contact FREDRIK ENGMAN
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/30/2008
Decision Date 03/02/2009
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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