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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
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