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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, Cemented
510(k) Number K840643
Device Name HARRIS-GALANTE POROUS TOTAL HIP SYS
Applicant
ZIMMER, INC.
P.O. Box 708
Warsaw,  IN  46580
Applicant Contact Max Sherman
Correspondent
ZIMMER, INC.
P.O. Box 708
Warsaw,  IN  46580
Correspondent Contact Max Sherman
Regulation Number888.3350
Classification Product Code
JDI  
Date Received02/15/1984
Decision Date 04/17/1984
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
Recalls CDRH Recalls
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