FDA 510(k) Application Details - K052302

Device Classification Name Graft, Vascular, Synthetic/Biologic Composite

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510(K) Number K052302
Device Name Graft, Vascular, Synthetic/Biologic Composite
Applicant BOSTON SCIENTIFIC CORP.
2 SCIMED PLACE
MAPLE GROVE, MN 55311-1566 US
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Contact JENNIFER BOLTON
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Regulation Number 870.3450

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Classification Product Code MAL
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Date Received 08/24/2005
Decision Date 09/12/2005
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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