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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/polymer, porous uncemented
510(K) Number K033034
Device Name VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS
Applicant
ZIMMER, INC.
p.o. box 708
warsaw,  IN  46581 0708
Contact karen cain
Regulation Number888.3358
Classification Product Code
LPH  
Date Received10/06/2003
Decision Date 11/05/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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