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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K953714
Device Name ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE
Applicant
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Applicant Contact LYNETTE WHITAKER
Correspondent
ZIMMER, INC.
P.O. BOX 708
WARSAW,  IN  46581 -0708
Correspondent Contact LYNETTE WHITAKER
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/09/1995
Decision Date 11/20/1995
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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