FDA 510(k) Application Details - K100402

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K100402
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant BARD ACCESS SYSTEMS, INC.
605 NORTH 5600 WEST
SALT LAKE CITY, UT 84116 US
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Contact KIMBERLY GEISLER
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 02/16/2010
Decision Date 03/05/2010
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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