FDA 510(k) Application Details - K990198

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K990198
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant ALLIANCE MEDICAL, INC.
7800 COTE DE LIESSE
ST. LAURENT, QUEBEC H4T 1G1 CA
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Contact JAMES RIEDL
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 01/21/1999
Decision Date 06/29/1999
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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