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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 K082229
Device Name S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM
Applicant
VOLCANO CORPORATION
2870 KILGORE RD.
RANCHO CORDOVA,  CA  95670
Applicant Contact MAMTA VATS
Correspondent
VOLCANO CORPORATION
2870 KILGORE RD.
RANCHO CORDOVA,  CA  95670
Correspondent Contact MAMTA VATS
Regulation Number892.1560
Classification Product Code
IYO  
Date Received08/07/2008
Decision Date 10/08/2008
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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