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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
Applicant
Johnson & Johnson Professionals, Inc.
P.O. Box 386
King Of Prussia,  PA  19406
Applicant Contact J. TERESA DORRIETY
Correspondent
Johnson & Johnson Professionals, Inc.
P.O. Box 386
King Of Prussia,  PA  19406
Correspondent Contact J. TERESA DORRIETY
Regulation Number888.3320
Classification Product Code
JDL  
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
Predetermined Change
Control Plan Authorized		 No
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