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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 K061215
Device Name VOLCANO S51 FAMILY OF IMAGING SYSTEMS
Applicant
Volcano Corporation
2870 Kilgore Rd..
Rancho Cordova,,  CA  95670
Applicant Contact Michelle J Badal
Correspondent
Volcano Corporation
2870 Kilgore Rd..
Rancho Cordova,,  CA  95670
Correspondent Contact Michelle J Badal
Regulation Number892.1560
Classification Product Code
IYO  
Date Received05/02/2006
Decision Date 08/10/2006
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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