FDA 510(k) Application Details - K991469

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K991469
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant AAC CONSULTING GROUP, INC.
7475 WISCONSIN AVE., SUITE 850
BETHESDA, MD 20814 US
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Contact EDUARDO MARCH
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 04/28/1999
Decision Date 07/20/1999
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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