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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
Original Applicant
ZIMMER, INC.
p.o. box 708
warsaw,  IN  46581 0708
Original 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)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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