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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, Metal
510(k) Number K023882
Device Name THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
Applicant
Implex Corp.
80 Commerce Dr.
Allendale,  NJ  07401 -1600
Applicant Contact ROBERT POGGIE
Correspondent
Implex Corp.
80 Commerce Dr.
Allendale,  NJ  07401 -1600
Correspondent Contact ROBERT POGGIE
Regulation Number878.3300
Classification Product Code
EZX  
Date Received11/21/2002
Decision Date 02/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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