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FDA 510(k) Application Details - K043139
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device
510(K) Number
K043139
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
USCOM, LTD.
1700 ROCKVILLE PIKE
SUITE 400
ROCKVILLE, MD 20852 US
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Contact
CHRISTINA KICHULA
Other 510(k) Applications for this Contact
Regulation Number
892.1550
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Classification Product Code
IYN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/12/2004
Decision Date
02/15/2005
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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