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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 K040389
FOIA Releasable 510(k) K040389
Device Name COONRAD/MORREY ELBOW CEMENT RESTRICTOR
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact NOAH J BARTSCH
Correspondent
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact NOAH J BARTSCH
Regulation Number888.3150
Classification Product Code
JDC  
Subsequent Product Code
JDB  
Date Received02/17/2004
Decision Date 05/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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