FDA 510(k) Application Details - K022860

Device Classification Name Transducer, Ultrasonic, Diagnostic

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510(K) Number K022860
Device Name Transducer, Ultrasonic, Diagnostic
Applicant BOSTON SCIENTIFIC, TARGET
47900 BAYSIDE PKWY.
FREMONT, CA 94538 US
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Contact IRENE JAWORSKI
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Regulation Number 892.1570

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Classification Product Code ITX
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Date Received 08/28/2002
Decision Date 11/21/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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