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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 Cemented Acetabular Component)
510(k) Number K073499
Device Name VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES
Applicant
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581 -0708
Applicant Contact ERIC S PITTMAN
Correspondent
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46581 -0708
Correspondent Contact ERIC S PITTMAN
Regulation Number888.3320
Classification Product Code
JDL  
Subsequent Product Code
LPH  
Date Received12/13/2007
Decision Date 08/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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