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FDA 510(k) Application Details - K100402
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
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510(K) Number
K100402
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
BARD ACCESS SYSTEMS, INC.
605 NORTH 5600 WEST
SALT LAKE CITY, UT 84116 US
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Contact
KIMBERLY GEISLER
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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
02/16/2010
Decision Date
03/05/2010
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
Y
Expedited Review
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