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FDA 510(k) Application Details - K031066
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device
510(K) Number
K031066
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
EP MEDSYSTEMS
COOPER RUN EXECUTIVE PARK
575 ROUTE 73 N. BLDG. D
WEST BERLIN, NJ 08091 US
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Contact
JOHN J TALARICO
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
04/03/2003
Decision Date
10/17/2003
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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