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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K203115
Device Name ARVIS Surgical Navigation System
Applicant
Insight Medical Systems Inc.
25892 La Cuesta Avenue
Laguna Hills,  CA  92653
Applicant Contact Nicholas R. van der Walt
Correspondent
Bob Duffy Associates, Inc.
16405 Summer Sage Rd.
Poway,  CA  92064
Correspondent Contact Bob Duffy
Regulation Number882.4560
Classification Product Code
OLO  
Date Received10/16/2020
Decision Date 07/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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