FDA 510(k) Application Details - K960625

Device Classification Name Introducer, Catheter

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510(K) Number K960625
Device Name Introducer, Catheter
Applicant NEOSTAR MEDICAL TECHNOLOGIES, INC.
100 ROSS RD.
KING OF PRUSSIA, PA 19406 US
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Contact DAVID W WEAVER III
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Regulation Number 870.1340

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Classification Product Code DYB
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Date Received 02/13/1996
Decision Date 08/08/1996
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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