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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 K883665
FOIA Releasable 510(k) K883665
Device Name COONRAD III TOTAL ELBOW
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact HENRY A QUELLO
Correspondent
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact HENRY A QUELLO
Regulation Number888.3150
Classification Product Code
JDC  
Date Received08/26/1988
Decision Date 02/03/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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