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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 K192579
Device Name X-Guide Surgical Navigation System
Applicant
X-Nav Technologies,Llc.
1555 Bustard Rd.
Suite 75
Lansdale,  PA  19446
Applicant Contact Fred Cowdery
Correspondent
X-Nav Technologies,Llc.
1555 Bustard Rd.
Suite 75
Lansdale,  PA  19446
Correspondent Contact Fred Cowdery
Regulation Number872.4120
Classification Product Code
PLV  
Date Received09/19/2019
Decision Date 02/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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