FDA 510(k) Application Details - K073196

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K073196
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant SONOMED, INC.
377 ROUTE 17 S
HASBROUCK HEIGHTS, NJ 07604 US
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Contact GEORGE MYERS
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 11/13/2007
Decision Date 12/19/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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