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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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More FDA Info for this Product Code
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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