FDA 510(k) Application Details - K971790

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K971790
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant UROMETRICS, INC.
445 ETNA ST., SUITE 56
ST. PAUL, MN 55106 US
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Contact PHILLIP A MESSINA
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 05/14/1997
Decision Date 12/17/1997
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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