FDA 510(k) Application Details - K120882

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K120882
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant BARD ACCESS SYSTEMS, INC.
605 NORTH 5600 WEST
SALT LAKE CITY, UT 84116 US
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Contact HENRY BOLAND
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 03/23/2012
Decision Date 05/30/2012
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 Y
Expedited Review



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