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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 K140069
Device Name LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0
Applicant
Merete Medical GmbH
102 Alt Lankwitz
Berlin,  DE D-12247
Applicant Contact EMMANUEL ANAPLIOTIS
Correspondent
Merete Medical GmbH
102 Alt Lankwitz
Berlin,  DE D-12247
Correspondent Contact EMMANUEL ANAPLIOTIS
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received01/13/2014
Decision Date 04/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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