FDA 510(k) Application Details - K090229

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K090229
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant CHANG GUNG MEDICAL SUPPLIES & EQUIPMENT CORP.
7263 CRONIN CIRCLE
DUBLIN, CA 94568 US
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Contact BOB LEIKER
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 01/30/2009
Decision Date 03/13/2009
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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