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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K190074
Device Name Presero 3D Scanning System
Applicant
Certis Health
3630 Park Central Boulevard North
Pompano Beach,  FL  33064
Applicant Contact Richard Vogel Vogel
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/16/2019
Decision Date 02/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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