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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 K051920
Device Name VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001
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 Received07/15/2005
Decision Date 08/19/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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