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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical
510(k) Number K844225
Device Name LINK ACETABULAR MESH
Applicant
WALDEMAR LINK GMBH & CO. KG
10 GREAT MEADOW LN.
E. HANOVER,  NJ  07936
Applicant Contact ED SCHUSSLER
Correspondent
WALDEMAR LINK GMBH & CO. KG
10 GREAT MEADOW LN.
E. HANOVER,  NJ  07936
Correspondent Contact ED SCHUSSLER
Regulation Number878.3300
Classification Product Code
FTM  
Date Received11/01/1984
Decision Date 11/14/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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