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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
510(k) Number K192946
Device Name DePuy Corail AMT Hip Prosthesis
Applicant
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
warsaw,  IN  46582
Applicant Contact kathy harris
Correspondent
DePuy (Ireland)
Loughbeg, Ringaskiddy
cork,  IE p43ed82
Correspondent Contact susan mullane
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
KWL   KWY   MEH  
Date Received10/18/2019
Decision Date 11/26/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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