FDA 510(k) Application Details - K933334

Device Classification Name Wire, Guide, Catheter

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510(K) Number K933334
Device Name Wire, Guide, Catheter
Applicant BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
WATERTOWN, MA US
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Contact PAMELA L CADORETTE
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 07/08/1993
Decision Date 01/26/1994
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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