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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 K150561
Device Name NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System
Applicant
Narang Medical Limited
46, Naraina Industriall Area, Phase 1, New Delhi 11028
New Delhi,  IN 110028
Applicant Contact Vivek Narang
Correspondent
Narang Medical Limited
46, Naraina Industriall Area, Phase 1
New Delhi,  IN 110028
Correspondent Contact Vivek Narang
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received03/06/2015
Decision Date 11/25/2015
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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