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FDA 510(k) Application Details - K961073
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K961073
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
ATLANTIS DIAGNOSTICS INTL., INC.
18939 120TH AVENUE N.E.
SUITE 111
BOTHELL, WA 98011 US
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Contact
TERRENCE J SWEENEY
Other 510(k) Applications for this Contact
Regulation Number
892.1560
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Classification Product Code
IYO
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More FDA Info for this Product Code
Date Received
03/18/1996
Decision Date
02/19/1997
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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