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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
Original Applicant
ZIMMER, INC.
p.o. box 708
warsaw,  IN  46581 0708
Original 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 (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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