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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 K161756
Device Name SyncVision System
Applicant
Volcano Corporation
3721 Valley Ctr. Dr.
San Diego,  CA  92130
Applicant Contact Elaine Alan
Correspondent
Volcano Corporation
3721 Valley Ctr. Dr.
San Diego,  CA  92130
Correspondent Contact Elaine Alan
Regulation Number892.1650
Classification Product Code
OWB  
Date Received06/27/2016
Decision Date 09/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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