FDA 510(k) Application Details - K070982

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K070982
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS
7263 CRONIN CIRCLE
DUBLIN, CA 94568 US
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Contact BOB LEIKER
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 04/06/2007
Decision Date 05/02/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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