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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 K153716
Device Name GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.
Applicant
Gpc Medical, Ltd.
M-Block, Dda Lsc,
Vikas Puri,
New Delhi,  IN 110018
Applicant Contact VIKAS NARANG
Correspondent
Gpc Medical, Ltd.
M-Block, Dda Lsc,
Vikas Puri,
New Delhi,  IN 110018
Correspondent Contact VIKAS NARANG
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received12/24/2015
Decision Date 05/17/2016
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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