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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 K944769
Device Name P.F.C. APICAL PLUG
Original Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
p.o. box 386
king of prussia,  PA  19406
Original Contact j. teresa dorriety
Regulation Number888.3320
Classification Product Code
JDL  
Date Received09/27/1994
Decision Date 12/08/1994
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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