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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K121495
Device Name LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG
Applicant
AAP IMPLANTATE AG
LORENZWEG 5
BERLIN,  DE 12099
Applicant Contact MARC SEEGERS
Correspondent
AAP IMPLANTATE AG
LORENZWEG 5
BERLIN,  DE 12099
Correspondent Contact MARC SEEGERS
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received05/21/2012
Decision Date 12/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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