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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 K033243
Device Name ITI SYNOCTA MESO ABUTMENTS
Applicant
STRAUMANN USA
RESERVOIR PLACE,
1601 TRAPELO ROAD
WALTHAM,  MA  02154
Applicant Contact LINDA JALBERT
Correspondent
STRAUMANN USA
RESERVOIR PLACE,
1601 TRAPELO ROAD
WALTHAM,  MA  02154
Correspondent Contact LINDA JALBERT
Regulation Number872.3630
Classification Product Code
NHA  
Date Received10/07/2003
Decision Date 10/20/2003
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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