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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 K053624
Device Name MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM
Applicant
Medicon EG
Amstel 320-I
Amsterdam, Nh,  NL 1017AP
Applicant Contact ANGELIKA SCHERP
Correspondent
Medicon EG
Amstel 320-I
Amsterdam, Nh,  NL 1017AP
Correspondent Contact ANGELIKA SCHERP
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/28/2005
Decision Date 07/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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