FDA 510(k) Application Details - K051920

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K051920
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant VOLCANO CORPORATION
2870 KILGORE RD.
RANCHO CORDOVA, CA 95670 US
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Contact Michelle J Badal
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 07/15/2005
Decision Date 08/19/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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