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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K960425
Device Name BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX
Applicant
Endotec, Inc.
111 Orange St.
Bloomfield,  NJ  07003
Applicant Contact GEORGE MAKRIS,MSME
Correspondent
Endotec, Inc.
111 Orange St.
Bloomfield,  NJ  07003
Correspondent Contact GEORGE MAKRIS,MSME
Regulation Number888.3350
Classification Product Code
JDI  
Date Received01/29/1996
Decision Date 10/03/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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