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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 K200348
Device Name Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
Applicant
Neocis, Inc.
2800 Biscayne Blvd., Suite 600
Miami,  FL  33137
Applicant Contact Thomas E. Claiborne
Correspondent
Neocis, Inc.
2800 Biscayne Blvd., Suite 600
Miami,  FL  33137
Correspondent Contact Thomas E. Claiborne
Regulation Number872.4120
Classification Product Code
PLV  
Date Received02/12/2020
Decision Date 05/08/2020
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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