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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 K152602
Device Name Olea Sphere V3.0
Applicant
OLEA MEDICAL
93 AVENUE DES SORBIERS, ZONE ATHELIA IV
LA CIOTAT,  FR 13600
Applicant Contact CAROLINE LENE
Correspondent
OLEA MEDICAL
93 AVENUE DES SORBIERS, ZONE ATHELIA IV
LA CIOTAT,  FR 13600
Correspondent Contact CAROLINE LENE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/11/2015
Decision Date 03/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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