FDA 510(k) Application Details - K073623

Device Classification Name Transducer, Ultrasonic, Diagnostic

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510(K) Number K073623
Device Name Transducer, Ultrasonic, Diagnostic
Applicant BOSTON SCIENTIFIC CORP.
47900 BAYSIDE PARKWAY
FREMONT, CA 94538-6515 US
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Contact EMILLY TOJIMA
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Regulation Number 892.1570

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Classification Product Code ITX
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Date Received 12/26/2007
Decision Date 03/13/2008
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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