FDA 510(k) Application Details - K153106

Device Classification Name Wire, Guide, Catheter

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510(K) Number K153106
Device Name Wire, Guide, Catheter
Applicant ASAHI INTECC CO., LTD.
1703 WAKITA-CHO, MORIYAMA-KU
NAGOYA 463-0024 JP
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Contact Yoshihiko Fukui
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 10/27/2015
Decision Date 06/21/2016
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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