FDA 510(k) Application Details - K051679

Device Classification Name Catheter, Ultrasound, Intravascular

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510(K) Number K051679
Device Name Catheter, Ultrasound, Intravascular
Applicant BOSTON SCIENTIFIC CORP.
47201 LAKEVIEW BLVD.
FREMONT, CA 94537 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 06/23/2005
Decision Date 07/14/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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