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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dental stereotaxic instrument
510(k) Number K213392
Device Name INLIANT Surgical Navigation System
Applicant
Navigate Surgical Technologies Inc.
302 - 25 E. 6th Ave.
Vancouver,  CA V5T 1J3
Applicant Contact Marty Dymek
Correspondent
Pamela Buckman, MSN
921 Calle Verde
Martinez,  CA  94553
Correspondent Contact Pamela Buckman
Regulation Number872.4120
Classification Product Code
PLV  
Date Received10/15/2021
Decision Date 02/22/2022
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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