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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, Acetabular, Hip, Prosthesis
510(k) Number K972760
Device Name LINK, ACETABULAR REVISION MESH CUP
Applicant
Link America, Inc.
321 Palmer Rd.
Denville,  NJ  07834
Applicant Contact DOUGLAS W STUART
Correspondent
Link America, Inc.
321 Palmer Rd.
Denville,  NJ  07834
Correspondent Contact DOUGLAS W STUART
Regulation Number878.3300
Classification Product Code
JDJ  
Date Received07/24/1997
Decision Date 10/22/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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