FDA 510(k) Application Details - K081417

Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal

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510(K) Number K081417
Device Name Catheter, Angioplasty, Peripheral, Transluminal
Applicant ABBOTT VASCULAR INC.
3200 Lakeside Drive
Santa Clara, CA 95054 US
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Contact NADINE SMITH
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Regulation Number 870.1250

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Classification Product Code LIT
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Date Received 05/20/2008
Decision Date 06/04/2008
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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