FDA 510(k) Application Details - K020754

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K020754
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant NICOLET BIOMEDICAL
800 LEVANGER LN.
STOUGHTON, WI 53589 US
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Contact Gary Syring
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 03/07/2002
Decision Date 04/21/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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