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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 K190535
Device Name BiMobile Dual Mobility System - E-Dur Inserts
Applicant
Waldemar Link GmbH & Co. KG
Oststrasse 4-10
Norderstedt,  DE 22844
Applicant Contact Stefanie Fuchs
Correspondent
Waldemar Link GmbH & Co. KG
Oststrasse 4-10
Norderstedt,  DE 22844
Correspondent Contact Stefanie Fuchs
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received03/04/2019
Decision Date 08/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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