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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K141377
Device Name BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD
Applicant
Merete Medical GmbH
Alt Lankwitz 102
Berlin,  DE 12247
Applicant Contact EMMANUEL ANAPLIOTIS
Correspondent
Merete Medical GmbH
Alt Lankwitz 102
Berlin,  DE 12247
Correspondent Contact EMMANUEL ANAPLIOTIS
Regulation Number888.3353
Classification Product Code
LZO  
Date Received05/27/2014
Decision Date 11/21/2014
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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