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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 K202657
Device Name Javelin Tailor's Bunion Fixation System
Applicant
Nvision Biomedical Technologies, Inc.
4590 Lockhill Selma
San Antonio,  TX  78249
Applicant Contact Diana Langham
Correspondent
Nvision Biomedical Technologies
4590 Lockhill Selma
San Antonio,  TX  78249
Correspondent Contact Analaura Villarreal-Berain
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received09/14/2020
Decision Date 12/14/2020
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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