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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 K993465
Device Name DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE
Applicant
DEPUY, INC.
700 orthopaedic dr.
p.o. box 988
warsaw,  IN  46581 0988
Contact arlene c saull
Regulation Number888.3030
Classification Product Code
HRS  
Date Received10/13/1999
Decision Date 01/11/2000
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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