FDA 510(k) Application Details - K946277

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K946277
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant TETRA CORP.
357 INVERNESS DRIVE SOUTH
UNIT A
ENGLEWOOD, CO 80112-5816 US
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Contact DENNIS R DIETZ
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 12/27/1994
Decision Date 03/15/1996
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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