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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 K150222
FOIA Releasable 510(k) K150222
Device Name X-Guide Surgical Navigation System
Applicant
X-Nav Technologies, LLC
1555 Bustard Road, Suite 75
Lansdale,  PA  19446
Applicant Contact Fred Cowdery
Correspondent
X-Nav Technologies, LLC
1555 Bustard Road, Suite 75
Lansdale,  PA  19446
Correspondent Contact Fred Cowdery
Regulation Number872.4120
Classification Product Code
PLV  
Date Received01/30/2015
Decision Date 10/08/2015
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
Recalls CDRH Recalls
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