FDA 510(k) Application Details - K012867

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K012867
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant MEDISON AMERICA, INC.
16303 PANORAMIC WAY
SAN LEANDRO, CA 94578-1116 US
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Contact GARY J ALLSEBROOK
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 08/27/2001
Decision Date 09/12/2001
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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