FDA 510(k) Application Details - K122573

Device Classification Name Wire, Guide, Catheter

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510(K) Number K122573
Device Name Wire, Guide, Catheter
Applicant ABBOTT VASCULAR INC.
26531 YNEZ ROAD, BUILDING G
MALING P.O. 9018
TEMECULA, CA 92590-9018 US
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Contact KAY SETZER
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 08/23/2012
Decision Date 11/20/2012
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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