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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K040643
Device Name BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES
Applicant
Branemark Integration AB
Lilla Bommen 1
Goteborg,  SE SE-411 04
Applicant Contact JAN-OLOF DJERF
Correspondent
Branemark Integration AB
Lilla Bommen 1
Goteborg,  SE SE-411 04
Correspondent Contact JAN-OLOF DJERF
Regulation Number872.3640
Classification Product Code
DZE  
Date Received03/11/2004
Decision Date 04/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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