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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, hemi-, femoral, metal/polymer, cemented or uncemented
510(k) Number K221794
Device Name Vario-Cup System
Applicant
Waldemar Link GmbH & Co. KG
Oststraße 4-10
Norderstedt,  DE 22844
Applicant Contact Pia Mueller
Correspondent
LinkBio Corp.
69 King Street
Dover,  NJ  07801
Correspondent Contact Mateusz Leszczak
Regulation Number888.3390
Classification Product Code
KWY  
Date Received06/21/2022
Decision Date 07/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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