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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K160357
Device Name TRINITY
Applicant
Koelis
5 Ave. Du Grand Sablon
La Tronche,  FR 38700
Applicant Contact LAETITIA GERVAIS
Correspondent
Koelis
5 Ave. Du Grand Sablon
La Tronche,  FR 38700
Correspondent Contact LAETITIA GERVAIS
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   LLZ  
Date Received02/08/2016
Decision Date 05/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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