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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 K130808
Device Name STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS
Applicant
STRAUMANN USA
60 MINUTEMAN ROAD
ANDOVER,  MA  01810
Applicant Contact ELAINE ALAN
Correspondent
STRAUMANN USA
60 MINUTEMAN ROAD
ANDOVER,  MA  01810
Correspondent Contact ELAINE ALAN
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/25/2013
Decision Date 06/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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