FDA 510(k) Application Details - K960200

Device Classification Name Introducer, Catheter

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510(K) Number K960200
Device Name Introducer, Catheter
Applicant MSI, INC.
615 JASMINE AVENUE N.
TARPON SPRINGS, FL 34689 US
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Contact LARRY G JUNKER
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Regulation Number 870.1340

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Classification Product Code DYB
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Date Received 01/03/1996
Decision Date 07/02/1996
Decision SESE - SUBST EQUIV
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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