FDA 510(k) Application Details - K041727

Device Classification Name Catheter, Ultrasound, Intravascular

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510(K) Number K041727
Device Name Catheter, Ultrasound, Intravascular
Applicant BOSTON SCIENTIFIC SCIMED, INC.
47900 BAYSIDE PKWY.
FREEMONT, CA 94538 US
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Contact ROBERT Z PHILLIPS
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Regulation Number 870.1200

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Classification Product Code OBJ
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Date Received 06/25/2004
Decision Date 07/23/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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