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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name computer, diagnostic, pre-programmed, single-function
510(k) Number K181372
Device Name Argos
Applicant
Retia Medical, LLC
7 Dana Rd. Suite 111
valhalla,  NY  10595
Applicant Contact marc zemel
Correspondent
Retia Medical, LLC
7 Dana Rd. Suite 111
valhalla,  NY  10595
Correspondent Contact jerry korten
Regulation Number870.1435
Classification Product Code
DXG  
Date Received05/23/2018
Decision Date 12/13/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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