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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, Femoral, Resurfacing
510(k) Number K904870
Device Name MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON
Applicant
Endotec, Inc.
20 Valley St.
South Orange,  NJ  07079
Applicant Contact MICHAEL J PAPPAS
Correspondent
Endotec, Inc.
20 Valley St.
South Orange,  NJ  07079
Correspondent Contact MICHAEL J PAPPAS
Regulation Number888.3400
Classification Product Code
KXA  
Date Received10/23/1990
Decision Date 05/23/1991
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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