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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 K071838
Device Name NEOSS VARIOUS TITANIUM ABUTMENTS
Applicant
NEOSS LTD
WINDSOR HOUSE, CORNWALL ROAD
HARROGATE,  GB HGI2PW
Applicant Contact FREDRIK ENGMAN
Correspondent
NEOSS LTD
WINDSOR HOUSE, CORNWALL ROAD
HARROGATE,  GB HGI2PW
Correspondent Contact FREDRIK ENGMAN
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/05/2007
Decision Date 10/19/2007
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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