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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
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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