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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K203811
Device Name GPC Intraheal Intramedullary Nailing System
Applicant
Gpc Medical Limited
Gpc Sq., M-Block, Dda Lsc, Vikas Puri, New Delhi
New Delhi,  IN 110018
Applicant Contact Vikas Narang
Correspondent
Gpc Medical Limited
Gpc Sq., M-Block, Dda Lsc, Vikas Puri, New Delhi
New Delhi,  IN 110018
Correspondent Contact Vikas Narang
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Codes
HTY   HWC   JDS   JDW  
Date Received12/28/2020
Decision Date 02/10/2022
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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