FDA 510(k) Application Details - K072719

Device Classification Name Introducer, Catheter

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510(K) Number K072719
Device Name Introducer, Catheter
Applicant BOSTON SCIENTIFIC CORP.
2710 ORCHARD PARKWAY
SAN JOSE, CA 95134 US
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Contact CINDY MORROW
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Regulation Number 870.1340

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Classification Product Code DYB
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Date Received 09/25/2007
Decision Date 03/07/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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