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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 K113486
Device Name VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM
Applicant
VOLCANO CORPORATION
2870 KILGORE RD.
RANCHO CORDOVA,  CA  95670
Applicant Contact JWALA JAWHARKAR
Correspondent
VOLCANO CORPORATION
2870 KILGORE RD.
RANCHO CORDOVA,  CA  95670
Correspondent Contact JWALA JAWHARKAR
Regulation Number892.1560
Classification Product Code
IYO  
Date Received11/23/2011
Decision Date 01/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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