FDA 510(k) Application Details - K101985

Device Classification Name Wire, Guide, Catheter

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510(K) Number K101985
Device Name Wire, Guide, Catheter
Applicant ASAHI INTECC CO., LTD.
2500 RED HILL SUITE 210
SANTA ANA,, CA 92705 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 07/14/2010
Decision Date 03/07/2011
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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