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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K133142
Device Name VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION
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 Number892.1560
Classification Product Code
IYO  
Date Received10/17/2013
Decision Date 11/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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