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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 K182776
Device Name Neocis Guidance System
Applicant
Neocis Inc.
555 NW 29th ST
Miami,  FL  33127
Applicant Contact Thomas E. Claiborne
Correspondent
Neocis Inc.
555 NW 29th ST
Miami,  FL  33127
Correspondent Contact Thomas E. Claiborne
Regulation Number872.4120
Classification Product Code
PLV  
Date Received10/01/2018
Decision Date 12/21/2018
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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