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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K160088
Device Name Cydar EV
Applicant
Cydar Ltd.
Bulbeck Mill, Mill Lane
Barrington,  GB CB22 7QY
Applicant Contact John Clarke
Correspondent
Emergo Global Consulting, LLC
816 Congress Avenue, Suite 1400
Austin,  TX  78701
Correspondent Contact Richard A. Vincins
Regulation Number892.1650
Classification Product Code
OWB  
Date Received01/15/2016
Decision Date 07/07/2016
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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