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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 K153374
Device Name CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System
Applicant
Orthocare
3/10 Kirti Nagar Industrial Area
New Delhi,  IN 110015
Applicant Contact RAJEEV CHHABRA
Correspondent
Orthocare
3/10 Kirti Nagar Industrial Area
New Delhi,  IN 110015
Correspondent Contact RAJEEV CHHABRA
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received11/23/2015
Decision Date 06/17/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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