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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 K212442
Device Name Cydar EV (Series B) and Cydar EV Maps
Applicant
Cydar , Ltd.
Bulbeck Mill, Mill Lane
Barrington,  GB CB22 7QY
Applicant Contact Vanisha Mistry
Correspondent
Cydar , Ltd.
Bulbeck Mill, Mill Lane
Barrington,  GB CB22 7QY
Correspondent Contact Rob Hague
Regulation Number892.1650
Classification Product Code
OWB  
Date Received08/04/2021
Decision Date 12/03/2021
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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