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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, elbow, constrained, cemented
510(k) Number K053189
Device Name COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact LAURA D WILLIAMS
Correspondent
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact LAURA D WILLIAMS
Regulation Number888.3150
Classification Product Code
JDC  
Date Received11/15/2005
Decision Date 12/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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