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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 K222282
Device Name HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System
Applicant
Hospital Equipment Manufacturing Company
A19/A20, Sector 7
Noida,  IN 201301
Applicant Contact Himanshu Sachdeva
Correspondent
Hospital Equipment Manufacturing Company
A19/A20, Sector 7
Noida,  IN 201301
Correspondent Contact Himanshu Sachdeva
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received07/29/2022
Decision Date 10/27/2022
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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