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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K211014
Device Name Portray
Applicant
Surround Medical Systems
175 Southport Dr., Suite 900
Morrisville,  NC  27560
Applicant Contact Elizabeth Sullivan
Correspondent
Surround Medical Systems
175 Southport Dr., Suite 900
Morrisville,  NC  27560
Correspondent Contact Elizabeth Sullivan
Regulation Number872.1800
Classification Product Code
EHD  
Date Received04/05/2021
Decision Date 07/28/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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