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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 K191793
Device Name Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System
Applicant
Nebula Surgical Private Limited
Nebula, Narmada Park-3,Amin Marg, Vidyakunj Soc.Main Road
Opp.Kings Heigt
Rajkot,  IN 360005
Applicant Contact Rajat Kumar Khant
Correspondent
Nebula Surgical Private Limited
Nebula, Narmada Park-3,Amin Marg, Vidyakunj Soc.Main Road
Opp.Kings Heigt
Rajkot,  IN 360005
Correspondent Contact Rajat Kumar Khant
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received07/03/2019
Decision Date 12/09/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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