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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 K151904
Device Name SyncVision System
Applicant
Volcano Corporation
1 Fortune Dr.
Billerica,  MA  01821
Applicant Contact ELAINE ALAN
Correspondent
Volcano Corporation
1 Fortune Dr.
Billerica,  MA  01821
Correspondent Contact ELAINE ALAN
Regulation Number892.1650
Classification Product Code
OWB  
Date Received07/13/2015
Decision Date 07/31/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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