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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 K032344
Device Name THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330
Applicant
Implex Corp.
80 Commerce Dr.
Allendale,  NJ  07401
Applicant Contact MARCI HALEVI
Correspondent
Implex Corp.
80 Commerce Dr.
Allendale,  NJ  07401
Correspondent Contact MARCI HALEVI
Regulation Number878.3300
Classification Product Code
EZX  
Date Received07/30/2003
Decision Date 10/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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