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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 K963940
Device Name EXETER MESH
Applicant
Howmedica, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070
Applicant Contact FRANK MAAS
Correspondent
Howmedica, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070
Correspondent Contact FRANK MAAS
Regulation Number878.3300
Classification Product Code
JDJ  
Subsequent Product Code
JDI  
Date Received10/01/1996
Decision Date 02/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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