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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 K191363
Device Name Neocis Planning Software Application (NPSA) for 3rd Party PCs
Applicant
Neocis, Inc.
2800 Biscayne Blvd., Suite 600
Miami,  FL  33137
Applicant Contact Thomas ("Ted") E. Claiborne
Correspondent
Neocis, Inc.
2800 Biscayne Blvd., Suite 600
Miami,  FL  33137
Correspondent Contact Thomas ("Ted") E. Claiborne
Regulation Number872.4120
Classification Product Code
PLV  
Date Received05/22/2019
Decision Date 10/02/2019
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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