FDA 510(k) Application Details - K052517

Device Classification Name Transducer, Ultrasonic, Diagnostic

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510(K) Number K052517
Device Name Transducer, Ultrasonic, Diagnostic
Applicant C.R. BARD, INC.
5425 WEST AMELIA EARHART DR.
SALT LAKE CITY, UT 84116 US
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Contact KIMBERLY GEISLER
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Regulation Number 892.1570

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Classification Product Code ITX
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Date Received 09/14/2005
Decision Date 09/29/2005
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 Y
Expedited Review



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