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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 K200662
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  
Subsequent Product Code
DZL  
Date Received03/13/2020
Decision Date 05/21/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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