FDA 510(k) Application Details - K000004

Device Classification Name Introducer, Catheter

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510(K) Number K000004
Device Name Introducer, Catheter
Applicant DAIG CORP.
14901 DEVEAU PLACE
MINNETONKA, MN 55345-2126 US
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Contact PAUL CORNELISON
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Regulation Number 870.1340

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Classification Product Code DYB
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Date Received 01/03/2000
Decision Date 11/29/2000
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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