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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
p.o. box 386
king of prussia,  PA  19406
Original Contact j. teresa dorriety
Regulation Number888.3320
Classification Product Code
Date Received09/27/1994
Decision Date 12/08/1994
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No