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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 K192327
Device Name DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile
Applicant
Synthes (USA) Products LLC
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact Thomas Shea
Correspondent
Synthes (USA) Products LLC
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact Thomas Shea
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/27/2019
Decision Date 11/07/2019
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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