FDA 510(k) Application Details - K952551

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K952551
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant 3D ULTRASOUND, INC.
302 EAST PETTIGREW ST.
SUITE 307
DURHAM, NC US
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Contact JOHN OXAAL
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 06/02/1995
Decision Date 12/11/1995
Decision SE - Substantially Equivalent
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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