FDA 510(k) Application Details - K951976

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K951976
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant ALLIANCE MEDICAL, INC.
3610 VALIQUETTE ST.
ST-LAURENT, QUEBEC H4S 1X8 CA
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Contact KARIM MENASSA
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 04/27/1995
Decision Date 07/26/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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