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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
  No 510(k) holder with active listings identified
Current 510(k) Holder
No 510(k) holder with active listings identified
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
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