FDA 510(k) Application Details - K003398

Device Classification Name Wire, Guide, Catheter

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510(K) Number K003398
Device Name Wire, Guide, Catheter
Applicant BOSTON SCIENTIFIC CORPORATION NORTHWEST TECHNOLOGY
17425 N.E. UNION HILL RD.
REDMOND, WA 98052 US
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Contact JOCELYN KERSTEN
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 11/01/2000
Decision Date 12/01/2000
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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