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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 K040756
Device Name THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX
Applicant
IMPLEX CORP.
80 COMMERCE DR.
ALLENDALE,  NJ  07401 -1600
Applicant Contact MARCI HALEVI
Correspondent
IMPLEX CORP.
80 COMMERCE DR.
ALLENDALE,  NJ  07401 -1600
Correspondent Contact MARCI HALEVI
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
EZX  
Date Received03/24/2004
Decision Date 07/14/2004
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
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