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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Driver, Wire, And Bone Drill, Manual
510(k) Number K181813
Device Name ImmersiveView Surgical Plan (IVSP®)
Applicant
ImmersiveTouch
708 Kristin Court
Westmont,  IL  60559
Applicant Contact P. Pat Banerjee
Correspondent
ImmersiveTouch
708 Kristin Court
Westmont,  IL  60559
Correspondent Contact P. Pat Banerjee
Regulation Number872.4120
Classification Product Code
DZJ  
Subsequent Product Code
LLZ  
Date Received07/06/2018
Decision Date 06/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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