FDA 510(k) Application Details - K022928

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K022928
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant HUDSON DIAGNOSTIC IMAGING LLC
610 BLVD.
ELMWOOD PARK, NJ 07407 US
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Contact MARTIN E WENDELKEN
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 09/04/2002
Decision Date 12/11/2002
Decision SESE - SUBST EQUIV
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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