FDA 510(k) Application Details - K032615

Device Classification Name Wire, Guide, Catheter

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510(K) Number K032615
Device Name Wire, Guide, Catheter
Applicant ASAHI INTECC CO., LTD.
1100 QUAIL ST., SUITE 207
NEWPORT BEACH, CA 92660 US
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Contact YOSHI TERAI
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 08/25/2003
Decision Date 09/16/2003
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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