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FDA 510(k) Application Details - K073408
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
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510(K) Number
K073408
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA
9900 INNOVATION DR.
WAUWATOSA, WI 53226 US
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Contact
NICOLE LANDREVILLE
Other 510(k) Applications for this Contact
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
12/04/2007
Decision Date
12/19/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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