FDA 510(k) Application Details - K100989

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K100989
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant IMACOR INC.
50 CHARLES LINDBERGH BLVD
SUITE 200
UNIONDALE, NY 11553 US
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Contact RICHARD LANZILLOTTO
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 04/09/2010
Decision Date 06/25/2010
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 N
Expedited Review



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