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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K130003
Device Name XIRALITE FLOURESCENCE IMAGING SYSTEM X4
Applicant
Mivenion GmbH
Robert-Koch-Platz 4
Berlin,  DE 10115
Applicant Contact MALTE BAHNER
Correspondent
Mivenion GmbH
Robert-Koch-Platz 4
Berlin,  DE 10115
Correspondent Contact MALTE BAHNER
Regulation Number892.1600
Classification Product Code
IZI  
Subsequent Product Code
OWN  
Date Received01/02/2013
Decision Date 01/31/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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