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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, intraosseous
510(k) Number K130682
Device Name MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT
Applicant
HAGER & MEISINGER GMBH
HANSEMANNSTRASSE 10
NEUSS,  DE D-41468
Applicant Contact WIEBKE STOLTEN
Correspondent
HAGER & MEISINGER GMBH
HANSEMANNSTRASSE 10
NEUSS,  DE D-41468
Correspondent Contact WIEBKE STOLTEN
Regulation Number872.4880
Classification Product Code
DZL  
Date Received03/13/2013
Decision Date 08/13/2013
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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